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Antibacterial and Antifungal Product Labeling: Microbiology Susceptibility Interpretive Criteria (Breakpoints) and Quality Control Parameter Updates

Table Last Updated: June 22, 2016
New or Changes are in bold.

This table lists approved Antibacterial and Antifungal products whose Microbiology subsection, Susceptibility Interpretive Criteria and Quality Control Parameter information in the labeling, has been reviewed and is current. The labels for these products are posted on the Drugs@FDA or Daily Med websites.

Active Ingredient

Product Name

Company Name

Type of Application

Application Number

Date of Most Recent FDA Review of Microbiology Susceptibility Interpretive Criteria*

Amikacin

Amikacin Sulfate Injection, 250 mg/mL

Eurohealth/West-Ward

ANDA

63-315

5/11/16

Amikacin

Amikacin Sulfate Solution, Injection 50 mg/mL

Fresenius Kabi USA LLC

ANDA

205605

12/09/15

Amoxicillin

Amoxil (amoxicillin) Chewable Tablets  

Dr. Reddy's Laboratories 

NDA

50-542

09/24/15

Amoxicillin

Amoxil (amoxicillin)Tablets-BID 

Dr. Reddy's Laboratories 

NDA

50-754

09/24/15

Amoxicillin

Moxatag (amoxicillin extended-release) Tablets, 775 mg

Vernalis (R&D) Limited

NDA

50-813

06/09/15

Amoxicillin

Amoxicillin Tablets USP, 500 mg & 875 mg

Teva Pharmaceuticals USA

ANDA 

65-056

05/02/13

Amoxicillin 

Amoxil (amoxicillin) Chewable Tablets BID 

Dr. Reddy's Laboratories 

NDA

50-761

09/24/15

Amoxicillin 

Amoxil (amoxicillin) Oral Suspension - BID 

Dr. Reddy's Laboratories 

NDA

50-760

09/24/15

Amoxicillin

Amoxicillin for Suspension USP, 200 mg/5 mL and
400 mg/5 mL

Teva Pharmaceuticals USA

ANDA

65-119

11/20/12

Amoxicillin/clavulanate potassium

AUGMENTIN (amox/clavul pot) Tablets 250 & 500 mg

GlaxoSmithKline

NDA

50-564

09/29/11

Amoxicillin/clavulanate potassium

AUGMENTIN (amox/clav pot) Oral Susp 125 & 250 mg/5mL

GlaxoSmithKline

NDA

50-575

09/29/11

Amoxicillin/clavulanate potassium

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 200 mg/28.5mg per 5 mL & 400 mg/57 mg per 5 mL

Teva Pharmaceutical USA

ANDA

65-089

7/25/13

Amoxicillin/clavulanate potassium

Amoxicillin and Clavulanate Potassium Tablets, USP (chewable)
200 mg/28.5mg & 400 mg/57 mg

Teva Pharmaceutical USA

ANDA

65-205

07/08/13

Amoxicillin/clavulanate potassium

AUGMENTIN (amox/clav pot) Tablet '875'

GlaxoSmithKline

NDA

50-720

09/29/11

Amoxicillin/clavulanate potassium

AUGMENTIN XR (amoxicillin/clavulate potassium) Tablets, 1000mg/62.5mg

Dr. Reddy's Laboratories

NDA

50-785

08/26/11

Ampicillin sodium/sulfactam sodium 

Unasyn (ampicillin sodium/sulbactam sodium) for Injection

Pfizer, Inc.

NDA 

50-608

03/06/12

Ampicillin sodium/sulfactam sodium 

Unasyn (ampicillin sodium/sulbactam sodium) for Injection, 2gm/1gm, 1gm/500mg

Pfizer, Inc.

ANDA 

62-901

04/07/14

Ampicillin Sodium

Ampicillin for Injection USP, 125mg, 250mg, 500mg, 1g and 2g per vial and 10g Pharmacy Bulk Package

Sandoz, Inc.

ANDA

61-395

07/17/15

Ampicillin Trihydrate

Ampicillin Trihydrate Capsule 500 mg

DAVA Pharmaceuticals Inc.

ANDA

62-882

9/25/15

Ampicillin Trihydrate

Ampicillin Trihydrate Suspension 250 mg/ 5 mL

DAVA Pharmaceuticals Inc.

ANDA

62-982

9/25/15

Amphotericin B

AmBisome (amphotericin B) liposome for Injection

Astellas Pharma U.S. Inc.

NDA

50-740

03/08/12

Azithromycin

Zithromax (azithromycin for injection) IV

Pfizer, Inc.

NDA

50-733

11/16/11

Azithromycin

Zithromax (azithromycin for oral suspension) Single-Dose Packet

Pfizer, Inc.

NDA

50-693

11/02/12

Azithromycin

Zithromax (azithromycin for oral suspension)  

Pfizer, Inc.

NDA

50-710

11/02/12

Azithromycin

Zithromax (azithromycin) 250 mg Tablet  

Pfizer, Inc.

NDA

50-711

11/02/12

Azithromycin

Zithromax (azithromycin) 600 mg Tablet  

Pfizer, Inc.

NDA

50-730

11/02/12

Azithromycin

Zithromax (azithromycin) 500 mg Tablet  

Pfizer, Inc.

NDA

50-784

11/02/12

Azithromycin 

Zithromax (azithromycin) ER Tablet  

Pfizer, Inc.

NDA

50-797

10/11/13

Aztreonam 

AZACTAM (aztreonam for injection, USP)

Bristol Myers Squibb Co

NDA

50-580

06/17/13

Aztreonam 

AZACTAM (aztreonam injection) in GALAXY Plastic Container (PL 2040) for Intravenous Use

Bristol Myers Squibb Co

NDA 

50-632

06/17/13

Cefaclor

Cefaclor 500 mg Tablet Extended Release

Teva Pharmaceutical USA

ANDA

65-058

01/22/15

Cefaclor

Cefaclor Capsules, USP, 250 mg and 500 mg

West-Ward Pharmaceutical Corp.

ANDA

65-350

07/24/15

Cefaclor

Cefaclor Oral Suspension

Yung Shin Pharmaceutical Industrial Co. Ltd.

ANDA

65-412

10/14/15

Cefadroxil 

Cefadroxil Tablets, USP, 1000 mg

Teva Pharmaceuticals USA

ANDA

62-774

04/18/12

Cefadroxil hemihydrate 

Cefadroxil Hemihydrate Oral Suspension

Lupin

ANDA

65-396

04/18/14

Cefazolin & Dextrose 

Cefazolin for Injection, USP & Dextrose Injection in the Duplex Container, 1g Intravenous

B. Braun Medical, Inc.

NDA

50-779

10/08/15

Cefazolin

Cefazolin for Injection, USP, Pharmacy Bulk Package bags SmartPak 100g & 300g

Samson Medical Tech, LLC

ANDA

65-141

07/30/13

Cefazolin

Cefazolin for Injection USP, 10 g Pharmacy Bulk
Package

Hospira, Inc.

ANDA

65-247

01/17/13

Cefazolin

Cefazolin Injection, USP, 10 mg/mL and 20 mg/mL

Baxter Healthcare Corporation

ANDA

63-002

02/29/16

Cefazolin

Cefazolin Sodium,
20 gm/vial

Steri Pharma

ANDA

63-209

05/29/16

Cefdinir

Omnicef (cefdinir) Capsules

Abbott Laboratories

NDA

50-739

11/18/15

Cefdinir

Omnicef (cefdinir) Capsules

Abbott Laboratories

NDA

50-739

11/18/15

Cefditoren Pivoxil

Spectracef (cefditoren pivoxil) 200mg & 400 mg Tablets

Vansen Pharma

NDA 

21-222

08/06/12

Cefepime Hydrochloride

Maxipime (cefepime hydrochloride, USP) for Injection

Hospira, Inc.

NDA

50-679

05/01/14

Cefepime Hydrochloride

Cefepime (cefepime hydrochloride) Injection

Baxter Healthcare Corp

NDA

50-817

05/09/16

Cefepime

Cefepime for Injection USP and Dextrose Injection USP in Duplex Container

B. Braun Medical, Inc.

NDA

50-821

06/06/14

Cefixime

Suprax (cefixime) Oral Capsule 400 mg 

Lupin Ltd.

NDA

203195

01/07/16

Cefixime

Suprax (cefixime) for Oral Suspension 500 mg/5 mL

Lupin Ltd.

NDA 

202091

01/07/16

Cefixime

Cefixime Chewable Tablets, 200 mg

Lupin Ltd.

ANDA 

65-380

02/16/16

Cefixime

Cefixime Oral Tablets,
400 mg

Lupin Ltd

ANDA

65-130

02/16/16

Cefobid

Cefobid (cefoperazone sodium ) IM/IV

Pfizer Inc

NDA

50-551

03/18/15

Cefotaxime sodium

Claforan (cefotaxime sodium) Sterile IV/IM

Sanofi Aventis US LLC

NDA

50-547

 

03/03/15

Cefotaxime sodium

Claforan (cefotaxime sodium) Injection

Sanofi Aventis US LLC

NDA

50-596

03/03/15

Cefotaxime sodium

Cefotaxime Sodium Add Vantage 1 g & 2 g Vial

Sanofi Aventis US LLC

ANDA

62-659

03/03/15

Cefoxitin 

Mefoxin (cefoxitin for injection) 1g/10mL, 2g/20mL & 10g/100mL

Mylan Institutional LLC

NDA

50-517

05/10/13

Cefoxitin and Dextrose

Cefoxitin and Dextrose in Duplex Container

B.Braun Medical, Inc.

NDA

65-214

06/05/13

Cefpodoxime Proxetil

Cefpodoxime Proxetil Tablets USP, 100 mg and 200 mg

Sandoz Inc.

ANDA

65-462

02/05/14

Cefpodoxime Proxetil

Cefpodoxime Proxetil Oral Suspension,
100 mg/5 mL

Sandoz Inc.

ANDA

90-031

06/02/14

Ceftaroline fosamil

Teflaro (ceftaroline fosamil) for Injection

Cerexa, Inc.

NDA

200327

05/29/13

Ceftazidime

Ceftazidime in Dextrose Container

B. Braun

NDA

50-823

05/15/15

Ceftazidime - avibactam

AVYCAZ (ceftazidime-avibactam) for injection

Cerexa, Inc.

NDA

206494

02/25/15

Ceftazidime sodium

Fortaz (ceftazidime) Powder for Injection

Covis Injectables

NDA

50-578

09/24/14

Ceftazidime sodium

Fortaz (ceftazidime) in Plastic Container

Covis Injectables

NDA

50-634

09/24/14

Ceftibuten

CEDAX (ceftibuten) Capsules

Shionogi USA, Inc.

NDA

50-685

11/04/10

Ceftibuten

CEDAX (ceftibuten) Oral Suspension

Shionogi USA, Inc.

NDA

50-686

11/04/10

Ceftolozane and Tazobactam

ZERBAXA (ceftolozane and tazobactam)

Cubist Pharmaceuticals, Inc.

NDA

206829

12/19/14

Ceftriaxone sodium

Rocephin (ceftriaxone sodium) for Injection

Hoffman-La Roche, Inc.

NDA

50-585

06/30/15

Ceftriaxone sodium

Rocephin (ceftriaxone sodium)  for Injection,
500 mg and 1 gm vials

Hoffman-La Roche, Inc.

ANDA

63-239

06/25/15

Ceftriaxone sodium

Ceftriaxone for Injection, USP (ceftriaxone powder for injection, 250 mg, 500 mg, 1 & 2 g)

Sandoz, Inc.

ANDA

65-169

09/27/13

Ceftriaxone sodium

Ceftriaxone for Injection, USP (ceftriaxone powder for injection, 10 g per 100 mL Vial (PBP)

Sandoz, Inc.

ANDA

65-168

09/27/13

Ceftriaxone sodium

Ceftriaxone for Injection, 1 g & 2 g ADD-Vantage Vials

Sandoz, Inc.

ANDA

65-204

09/27/13

Ceftriaxone sodium

Ceftriaxone Sodium Injectable 1 mg &
500 mg base/vial

Sandoz, Inc.

ANDA

63-239

06/25/15

Ceftriaxone and Dextrose

Ceftriaxone for Injection and Dextrose Injection in the Duplex Container, 1g and 2g

B.Braun Medical, Inc.

NDA

50-796

07/09/15

Cefuroxime Axetil

Ceftin (cefuroxime axetil) Tablet

GlaxoSmithKline

NDA

50-605

06/26/15

Cefuroxime Axetil

Ceftin for Oral Suspension (cefuroxime axetil powder for oral suspension)

GlaxoSmithKline

NDA

50-672

06/26/15

Cefuroxime Sodium

Zinacef (cefuroxime) Powder for injection

Covis Injectables

NDA

50-558

09/25/14

Cefuroxime Sodium

Zinacef (cefuroxime) in Plastic Container

Covis Injectables

NDA

50-643

09/25/14

Cefuroxime

Cefuroxime for Injection USP and Dextrose Injection USP

B. Braun

NDA

50-780

05/01/15

Cephalexin

Keflex (cephalexin USP) Capsules

Shionogi, Inc.

NDA

50405

10/30/15

Cephalexin 

Cephalexin Tablets, 500 mg

Teva Pharmaceuticals

ANDA

63-024

04/18/12

Ciprofloxacin HCl

Cipro (ciprofloxacin HCl) Tablets

Bayer Healthcare Pharmaceuticals

NDA

19-537

01/30/13

Ciprofloxacin HCl

Cipro I.V. (ciprofloxacin hydrochloride) 1% Solution in Vials

Bayer Healthcare Pharmaceuticals

NDA

19-847

01/30/13

Ciprofloxacin HCl

Cipro (ciprofloxacin hydrochloride) Solution in 5% Dextrose

Bayer Healthcare Pharmaceuticals

NDA

19-857

01/30/13

Ciprofloxacin HCl

Cipro (ciprofloxacin HCl)  5% and 10% Oral Suspension

Bayer Healthcare Pharmaceuticals

NDA

20-780

01/30/13

Ciprofloxacin HCl

Cipro XR (ciprofloxacin HCl) Tablets

Bayer Healthcare Pharmaceuticals

NDA

21-473

 

01/30/15

Ciprofloxacin HCl

Ciprofloxacin Extended Release Tablets
500 mg and 1000 mg

Mylan Pharms Inc.

ANDA

78-183

8/14/13

Ciprofloxacin HCl

Proquin XR (ciprofloxacin hydrochloride)

Depomed, Inc.

NDA

21-744

12/29/10

Clarithromycin 

BIAXIN Filmtabs (clarithromycin tablets, USP)

Abbott Laboratories

NDA

50-662

05/03/12

Clarithromycin 

BIAXIN Granules (clarithromycin for oral suspension, USP)

Abbott Laboratories

NDA

50-698

05/03/12

Clarithromycin 

BIAXIN XL Filmtabs (clarithromycin ER tablets)

Abbott Laboratories

NDA

50-775

05/03/12

Clindamycin hydrochloride

Cleocin HCl (clindamycin hydrochloride) 75mg, 150 mg, 300 mg capsules

Pfizer, Inc. 

NDA

50-162 

03/23/16

Clindamycin phosphate and dextrose

Cleocin Phosphate (clindamycin phosphate with 5% dextrose) injection

Pfizer, Inc.

NDA

50-639

 

03/23/16

Clindamycin phosphate

Cleocin Phosphate (clindamycin phosphate, USP) Injection 

Pfizer, Inc.

NDA

50-441

 

03/23/16

Dalbavancin Hydrochloride

Dalvance (dalbavancin) for Injection, for intravenous use

Durata Therapeutics, Inc.

NDA

21-883

05/23/14

Daptomycin 

Cubicin (daptomycin for injection)

Cubist Pharmaceuticals

NDA

21-572

10/03/11

Demeclocycline hydrochloride

Declomycin (demeclocycline hydrochloride) Tablets

CorePharm LLC

NDA 

50-261

09/05/12

Demeclocycline hydrochloride

Demeclocycline hydrochloride Tablets USP, 150 mg and 300 mg

Amneal Pharm

ANDA

65-425

 

02/05/13

Dicloxacillin

Dicloxacillin Sodium Capsules, USP, 500 mg

Sandoz, Inc.

ANDA

61-454

01/26/16

Doripenem

DORIBAX (doripenem for injection)

Janssen Research and Development LLC

NDA

22-106

01/26/12

Doxycycline

DOXY 100 & 200TM (Doxycycline for Injection USP, 100 mg and 200 mg
per vial).

Fresenius Kabi USA, LLC

ANDA

62-475

01/28/14

Doxycycline

Doxycycline Capsules USP, 50 mg, 75 mg, 100 mg, and 150 mg

Par Pharmaceuticals, Inc.

ANDA

65-055

07/10/14

Doxycycline

Doxycycline Tablets 50, 75, 100, & 150 mg

Par Pharmaceuticals, Inc.

ANDA

65-070

12/20/15

Doxycycline monohydrate

Monodox (doxycycline monohydrate) Capsules

Watson Laboratories, Inc.

NDA

50-641

01/11/12

Doxycycline monohydrate

Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension

Pfizer, Inc.

NDA

50-006

09/12/14

Doxycycline hyclate

Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capsules

Pfizer, Inc.

NDA 

50-007

09/12/14

Doxycycline calcium 

Vibramycin Calcium (doxycycline calcium oral suspension, USP) Syrup

Pfizer, Inc.

NDA

50-480

 

09/12/14

Doxycycline hyclate 

Vibra-Tabs (doxycycline hyclate tablets, USP) Film Coated Tablets

Pfizer, Inc.

NDA 

50-533

 

09/12/14

Doxycycline hyclate

Doryx (doxycycline hyclate delayed release tablets) Tablets 80, 100, 150 & 200 mg

Mayne Pharma International

NDA

50-795

04/11/13

Doxycycline hyclate

Doxycycline Hyclate Tablets, USP 100 mg

West-Ward Pharmaceutical Corp

ANDA

65-095

06/25/14

Doxycycline hyclate

Doxycycline Hyclate Delayed-Release Capsules, 75 mg and 100 mg

Medicis Pharmaceutical Corporation

ANDA

65-281

12/21/15

Doxycycline hyclate

Doxycycline Hyclate Injection

Fresenius Kabi USA LLC

ANDA

62-475

01/26/16

Ertapenem sodium

Invanz (ertapenem sodium)

Merck, Sharp & Dohme

NDA

21-337

02/17/12

Erythromycin 

ERYC  (erythromycin delayed release capsules, USP) 250 mg

Mayne Pharma International

NDA 

50-536

03/21/13

Erythromycin

Erythromycin Tablets USP, 250 mg and 500 mg

Arbor Pharmaceuticals, Inc.

ANDA

61-621

12/04/13

Erythromycin

ERY-TAB (erythromycin delayed-release tablets, USP) Enteric-Coated, 250
mg, 333 mg, and 500 mg.

Arbor Pharmaceuticals, Inc

ANDA

62-298

12/04/13

Erythromycin ethylsuccinate 

E.E.S. Granules (erythromycin ethylsuccinate for oral suspension) EryPed 200, 400, & drops

Abbott Laboratories

NDA

50-207

11/04/10

Erythromycin ethylsuccinate

Ery-Ped Chewable Tablets (erythromycin ethylsuccinate, USP)

Abbott Laboratories

NDA

50-297

11/04/10

Erythromycin ethylsuccinate

EES (erythromycin ethylsuccinate oral suspension, USP)
Liquid 200 mg/5 mL and 400 mg/5 mL

Arbor Pharmaceuticals, Inc.

ANDA

61-639

10/31/13

Erythromycin ethylsuccinate

Erythromycin Ethylsuccinate Tablets USP, 400 mg.

Arbor Pharmaceuticals, Inc.

ANDA

61-904

12/04/13

Erythromycin ethylsuccinate

EES 400 Film-coated Tablets (erythromycin ethylsuccinate tablets, USP) 400 mg

Arbor Pharmaceuticals, Inc

ANDA

61-905

10/31/13

Erythromycin Ethylsuccinate and Sulfisoxazole Acetyl

Erythromycin ethylsuccinate and sulfisoxazole acetyl granule, for suspension, oral 200 mg base/5 mL

Barr Laboratories Inc.

ANDA

62-759

12/16/15

Erythromycin lactobionate

Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP)  vials

Hospira, Inc.

NDA

50-609

06/09/11

Erythromycin lactobionate

Erythromycin Lactobionate I.V. (erythromycin lactobioinate for injection, USP) 500 mg and 1 g ADD-Vantage Vials

Hospira, Inc.

ANDA

62-638

08/26/13

Erythromycin particles 

PCE Tablets (erythromycin particles in tablets) Dispertab Tablets

Abbott Laboratories

NDA

50-611

11/04/10

Erythromycin stearate

Erythrocin Stearate (erythromycin stearate tablets, USP) Film-coated Tablets, 250 mg

Arbor Pharmaceuticals, Inc.

ANDA

60-359

12/04/13

Fosfomycin tromethamine

Monurol (fosfomycin tromethamine) Sachet

Forest Laboratories, Inc.

NDA

50-717

03/15/10

Gemifloxacin mesylate

Factive (gemifloxacin mesylate) Tablet

Cornerstone Therapeutics, Inc.

NDA

21-158

10/18/11

Gentamicin Sulfate

Gentamicin Sulfate in 0.9% Sodium Chloride Injection in Plastic Container

Baxter Healthcare Corporation

ANDA

62-373

12/11/15

Gentamicin Sulfate

Gentamicin Sulfate Injection

Fresenius Kabi USA LLC

ANDA

62-366

03/07/14

Imipenem and Cilastatin

Primaxin I.V. (imipenem and cilastatin for injection)

Merck, Sharp & Dohme

NDA

50-587

04/16/12

Kanamycin Injection

Kanamycin Injection USP,
1 gm per 3 mL

Fresenius Kabi, USA, LLC

ANDA

65-111

07/15/15

Levofloxacin

Levaquin (levofloxacin) Tablet

Johnson & Johnson

NDA

20-634

06/10/11

Levofloxacin

Levaquin (levofloxacin) Injection

Johnson & Johnson

NDA

20-635

06/09/11

Levofloxacin

Levaquin (levofloxacin) Oral Solution

Johnson & Johnson

NDA

21-721

06/09/11

Lincomycin hydrochloride

Lincocin (lincomycin hydrochloride Injection, USP) Sterile Solution

Pfizer Inc.

NDA

50-317

10/15/14

Linezolid

Zyvox (linezolid) Tablets

Pfizer Inc.

NDA

21-130

06/05/15

Linezolid

Zyvox (linezolid) IV Injection

Pfizer Inc.

NDA

21-131

06/05/15

Linezolid

Zyvox (linezolid) Oral Suspension

Pfizer Inc.

NDA

21-132

06/05/15

Meropenem 

MERREM IV (meropenem for injection)

AstraZeneca UK Limited

NDA

50-706

03/28/13

Methenamine hippurate 

Hiprex (methenamine hippurate tablets, USP)

Sanofi Aventis

NDA

17-681

03/15/10

Metronidazole  

Metronidazole Injection, USP RTU in Plastic Container

Baxter Healthcare Corporation

NDA

18-657

07/13/15

Metronidazole  

Metronidazole Injection USP (5 mg/mL) in PAB Plastic Container

B. Braun

NDA

18-900

07/13/15

Metronidazole  

Metronidazole Injection USP, 500 mg (5 mg/mL) in Flexible Containers

Hospira

NDA

18-890

07/13/15

Metronidazole  

Flagyl (metronidazole) Tablets

GD Searle LLC

NDA

12-623

07/13/15

Metronidazole 
hydrochloride 

Flagyl (metronidazole hydrochloride) Intravenous

GD Searle LLC

NDA

18-353

07/13/15

Metronidazole  

Flagyl (metronidazole) Capsules

GD Searle LLC

NDA

20-334

07/13/15

Metronidazole  

Flagyl (metronidazole) Extended Release Tablets

GD Searle LLC

NDA

20-868

07/13/15

Micafungin sodium

Mycamine (micafungin sodium) For Injection; IV Infusion Only

Astellas Pharma U.S. Inc.

NDA

21-506

04/19/13

Minocycline 

Minocycline Capsules

Teva Pharmaceuticals 

ANDA

63-009

01/02/13

Minocycline Hydrochloride

Dynacin (minocycline hydrochloride tablets, USP) 50 mg, 75 mg and 100 mg

Par Pharmaceuticals Inc.

ANDA

65-131

05/11/12

Moxifloxacin hydrochloride

Avelox (moxifloxacin hydrochloride) Tablets

Bayer HealthCare Pharmaceuticals, Inc.

NDA

21-085

10/18/11

Moxifloxacin hydrochloride

Avelox (moxifloxacin hydrochloride) IV

Bayer HealthCare Pharmaceuticals, Inc.

NDA

21-277

10/18/11

Nafcillin

Nafcillin Injection, USP in Plastic Galaxy Container, PL 2040

Baxter Healthcare Corporation

NDA

50-655

11/09/11

Nafcillin

Nafcillin for Injection, USP

Sandoz, Inc

ANDA

62-527

01/04/16

Nafcillin

Nafcillin for Injection, USP

Sandoz, Inc

ANDA

62-732

01/13/16

Nalidixic acid

Negram (nalidixic acid)

Sanofi Aventis

NDA

14-214

11/28/12

Neomycin Sulfate 

Neomycin Sulfate Tablet, USP, 500 mg

Teva Pharmaceuticals

ANDA

60-304

11/30/11

Neomycin Sulfate 

Neo-fradin (neomycin sulfate Oral Solution, USP) 125 mg/5 mL

X Gen Pharmaceuticals, Inc.

ANDA

65-010

01/17/12

Nitrofurantoin 

Furadantin (nitrofurantoin) Oral Suspension

Shionogi, Inc.

NDA

9-175

11/04/13

Nitrofurantoin, Macrocrystalline

Macrodantin Capsules

Almatica Pharma

NDA

16-620

06/06/11

Nitrofurantoin; Nitrofurantoin, Macrocrystalline

Macrobid Capsules

P & G Pharmaceuticals

NDA

20-064

06/06/11

Norfloxacin

Noroxin (norfloxacin) Tablets

Merck, Sharp & Dohme

NDA

19-384

05/27/11

Ofloxacin

Ofloxacin Tablets
200 mg, 300 mg &
400 mg

Teva Pharmaceuticals USA

ANDA

76-182

04/10/14

Oritavancin diphosphate

Orbactiv (oritavancin diphosphate) Lyophilized Powder for Injection, 400 mg/vial

The Medicines Company

NDA

206334

08/06/14

Oxacillin

Oxacillin Injection, USP in Plastic Galaxy Container, PL 2040

Baxter Healthcare Corporation

NDA

50-640

01/06/15

Oxacillin

Oxacillin for Injection, USP

Sandoz, Inc.

ANDA

61-490

04/11/16

Penicillin G benzathine & penicillin G Procaine 

Bicillin C-R Disposable Syringe for Deep IM Injection Only & Bicillin C-R 900/300 2 mL Syringe

King Pharmaceuticals, Inc.

NDA

50-141

10/13/15

Penicillin G benzathine 

Bicillin L-A (pen G Benzathine Inj Solution) Disposable Syringe

King Pharmaceuticals, Inc.

NDA 

50-138

10/13/15

Penicillin G

Penicillin G Injection, USP in Galaxy Plastic Container 

Baxter Healthcare Corporation

NDA

50-638

04/16/12

Penicillin G

Penicillin G Procaine Injection, Suspension
1 mL and 2 mL Syringe

King Pharmaceuticals, Inc.

ANDA

60-101

12/16/15

Penicillin G Sodium

Penicillin G Sodium

Sandoz

ANDA

65-068

10/11/12

Penicillin V Potassium

Penicillin V Potassium

Sandoz

ANDA

64-071

10/11/12

Penicillin V Potassium

Penicillin V Potassium Tablets USP, 250 mg & 500 mg and Penicillin V Potassium for Oral Solution, USP, 125 mg/
5 mL and 250 mg/5 mL

Teva Pharmaceuticals USA, Inc.

ANDA

60-456

07/16/14

Piperacillin Sodium/ Tazobactam 

Zosyn (piperacillin and tazobactam) for Injection, 2.25g, 3.375g and 4.5g Vials & 40.5 Bulk Pharmacy Vials

Pfizer Inc.

NDA

50-684

09/06/13

Piperacillin Sodium/Tazobactam Sodium

Zosyn (piperacillin sodium/tazobactam sodium) in Galaxy Containers

Pfizer Inc.

NDA

50-750

09/06/13

Piperacillin Sodium

Piperacillin Sodium Injectable, 40 gm base/vial

Istituto Biochimico Italiano

ANDA

65-157

03/05/16

Piperacillin Sodium

Piperacillin Sodium Injectable, 2, 3, & 4 gm base/vial

Istituto Biochimico Italiano

ANDA

65-114

03/05/16

Polymyxin B Sulfate

Polymyxin B Sulfate Injection

Bedford Laboratories

ANDA

60-716

01/27/12

Quinupristin and dalfopristin

Synercid (quinupristin and dalfopristin for injection)

King Pharmaceuticals, Inc.

NDA

50-748

01/13/12

Spectinomycin hydrochloride

Trobicin (spectinomycin hydrochloride) Sterile Powder 

Pfizer, Inc. 

NDA

50-347

11/15/11

Streptomycin 

Streptomycin for Injection, USP, 1 gram

X Gen Pharmaceuticals, Inc.

ANDA

64-210

04/30/12

Sulfamethoxazole; Trimethoprim

Bactrim Tablets, USP and Bactrim DS (double strength) Tablets

URL Mutual Pharmaceutical 

NDA

17-377

06/28/10

Sulfamethoxazole; Trimethoprim

Sulfamethoxazole & Trimethoprim Injection 80 & 16 mg/mL

Teva Pharmaceuticals USA

ANDA

73-303

04/29/13

Sulfamethoxazole and Trimethoprim  

Sulfamethoxazole & Trimethoprim Oral Suspension, USP, 200 mg/40 mg per 5mL 

Hi Tech Pharmacal Co

ANDA

74-650

12/15/11

Tedizolid Phosphate

Sivextro (tedizolid phosphate) Tablet

Cubist Pharmaceuticals, Inc.

NDA

205435

06/20/14

Tedizolid Phosphate

Sivextro (tedizolid phosphate) Injection

Cubist Pharmaceuticals, Inc.

NDA

205436

06/20/14

Telavancin

Vibativ (telavancin) for Injection 250 & 750 mg

Theravance, Inc.

NDA

22-110

02/07/14

Telithromycin

Ketek (telithromycin) Tablet

Sanofi Aventis

NDA

21-144

03/09/15

Tetracycline Hydrochloride

Tetracycline Hydrochloride Capsules USP, 250 mg and 500 mg

IVAX Pharmaceuticals, Inc.

ANDA

60-704

01/27/14

Ticarcillin disodium & clavulanate potassium 

Timentin (Sterile ticarcillin disodium & clavulanate potassium) for IV Administration

GlaxoSmithKline

NDA

50-590

06/09/11

Ticarcillin disodium & Clavulante potassium (sterile)

Timentin Galaxy Plastic Container (sterile ticarcillin disodium & Clavulante potassium)

GlaxoSmithKline

NDA

50-658

06/09/11

Tigecycline

Tygacil (tigecycline)

Wyeth Pharmaceuticals

NDA

21-821

03/15/10

Tobramycin 

Tobramycin Injection USP, Pharmacy Bulk Package -1.2 gram

X Gen Pharmaceuticals, Inc.

ANDA

65-013

01/17/12

Tobramycin

TOBI (tobramycin inhalation solution, USP)

Novartis Pharmaceuticals Corp.

NDA

50-753

03/15/10

Tobramycin

Tobramycin Injection USP, 10 mg/ml

Hospira, Inc.

ANDA

63-112

01/12/12

Tobramycin

Tobramycin Injection USP, 40 mg/mL in 2 mL

Fresenius Kabi USA, LLC

ANDA

65-122

01/29/14

Tobramycin Sulfate 

Tobramycin in 0.9% Sodium Chloride Injection

Hospira, Inc.

ANDA

63-081

12/08/11

Tobramycin Sulfate

Tobramycin Injection USP, Pharmacy Bulk Package -2-grams

Hospira, Inc.

ANDA

63-116

12/08/11

Trimethoprim

Trimethoprim Tablets, 100 mg

Teva Pharmaceuticals

NDA

18-679

06/13/16

Vancomycin hydrochloride 

Vancocin (vancomycin hydrochloride, USP) Capsules

ViroPharma, Inc.

NDA

50-606

12/14/11

Vancomycin hydrochloride 

Vancomycin Hydrochloride for injection, USP, 500 mg vial

Hospira, Inc.

ANDA

62-911

11/30/11

Vancomycin hydrochloride

Vancomycin Hydrochloride for injection, USP, 1 gram vial

Hospira, Inc.

ANDA

62-912

11/30/11

Vancomycin hydrochloride 

Vancomycin Hydrochloride for injection, USP, 500 mg ADD-Vantage vial

Hospira, Inc.

ANDA

62-931

11/30/11

Vancomycin hydrochloride 

Vancomycin Hydrochloride for injection, USP, 1 gram ADD-Vantage vial

Hospira, Inc.

ANDA

62-933

11/30/11

Vancomycin Hydrochloride

Vancomycin Hydrochloride for Injection USP, Pharmacy
Bulk Package bottle - 5 grams

Hospira, Inc.

ANDA

63-076

05/22/12

Vancomycin 

VANCOCIN HCl (vancomycin injection, USP) in Galaxy Plastic Container 

Baxter Healthcare Corporation

NDA

50-671

01/17/12

Vancomycin 

Vancomycin hydrochloride injection 

APP/Fresenius

ANDA

62-663

02/16/16

Latest Update: 06/22/2016

 

Page Last Updated: 09/06/2016
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