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Antibacterial and Antifungal Product Labeling: Microbiology Susceptibility Interpretive Criteria (Breakpoints) and Quality Control Parameter Updates
Table Last Updated: May 13, 2013
New or Changes are in italics.
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* |
| Amoxicillin | Amoxil (amoxicillin) Chewable Tablets | Dr. Reddy's Laboratories | NDA | 50-542 | 11/16/11 |
| Amoxicillin | Amoxil (amoxicillin)Tablets-BID | Dr. Reddy's Laboratories | NDA | 50-754 | 11/16/11 |
| Amoxicillin | Amoxil (amoxicillin) Chewable Tablets BID | Dr. Reddy's Laboratories | NDA | 50-761 | 11/16/11 |
| Amoxicillin | Amoxil (amoxicillin) Oral Suspension - BID | Dr. Reddy's Laboratories | NDA | 50-760 | 11/16/11 |
| Amoxicillin/clavulanate potassium | AUGMENTIN (amox/clavul pot) Tablets 250 & 500 mg | GlaxoSmithKline | NDA | 50-564 | 9/29/11 |
| Amoxicillin/clavulanate potassium | AUGMENTIN (amox/clav pot) Oral Susp 125 & 250 mg/5mL | GlaxoSmithKline | NDA | 50-575 | 9/29/11 |
| Amoxicillin/clavulanate potassium | AUGMENTIN (amox/clav pot) Chew Tablets 125 & 250 mg | GlaxoSmithKline | NDA | 50-597 | 9/29/11 |
| Amoxicillin/clavulanate potassium | AUGMENTIN (amox/clav pot) Tablet '875' | GlaxoSmithKline | NDA | 50-720 | 9/29/11 |
| Amoxicillin/clavulanate potassium | AUGMENTIN (amox/clav pot) Oral Susp 200mg/5mL & 400mg/5mL BID | GlaxoSmithKline | NDA | 50-725 | 9/29/11 |
| Amoxicillin/clavulanate potassium | AUGMENTIN (amoxicillin/clavulanate potassium) Chew Tablets 200 & 400 BID | GlaxoSmithKline | NDA | 50-726 | 9/29/11 |
| Amoxicillin/clavulanate potassium | AUGMENTIN ES-600 (amoxicillin/clavulanate potassium) Powder for Oral Suspension | Dr. Reddy's Laboratories | NDA | 50-755 | 8/26/11 |
| Amoxicillin/clavulanate potassium | AUGMENTIN XR (amoxicillin/clavulate potassium) Tablets, 1000mg/62.5mg | Dr. Reddy's Laboratories | NDA | 50-785 | 8/26/11 |
| Ampicillin sodium/sulfactam sodium) for injection | Unasyn (ampicillin sodium/sulbactam sodium) for Injection | Pfizer, Inc. | NDA | 50-608 | 3/6/12 |
| Amphotericin B | AmBisome (amphotericin B) liposome for Injection | Astellas Pharma U.S. Inc. | NDA | 50-740 | 3/8/12 |
| 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 | 11/2/12 |
| Azithromycin | Zithromax (azithromycin for oral suspension) | Pfizer, Inc. | NDA | 50-710 | 11/2/12 |
| Azithromycin | Zithromax (azithromycin) 250 mg Tablet | Pfizer, Inc. | NDA | 50-711 | 11/2/12 |
| Azithromycin | Zithromax (azithromycin) 600 mg Tablet | Pfizer, Inc. | NDA | 50-730 | 11/2/12 |
| Azithromycin | Zithromax (azithromycin) 500 mg Tablet | Pfizer, Inc. | NDA | 50-784 | 11/2/12 |
| Cefadroxil Tablets, USP, 1000 mg | Cefadroxil Tablets, USP, 1000 mg | IVAX | ANDA | 62-774 | 4/18/12 |
| Cefazolin for Injection, USP & Dextrose Injection in the Duplex Container, 1g Intravenous | Cefazolin for Injection, USP & Dextrose Injection in the Duplex Container, 1g Intravenous | B.Braun Medical, Inc. | NDA | 50-779 | 4/23/12 |
| Cefdinir | OMNICEF (cefdinir) Capsules | Abbott Laboratories | NDA | 50-739 | 6/28/10 |
| Cefdinir | OMNICEF (cefdinir) for Oral Suspension | Abbott Laboratories | NDA | 50-749 | 6/28/10 |
| Cefditoren Pivoxil | Spectracef (cefditoren pivoxil) 200mg & 400 mg Tablets | Vansen Pharma | NDA | 21-222 | 8/6/12 |
| Ceftibuten | CEDAX (ceftibuten) Capsules | Shionogi USA, Inc. | NDA | 50-685 | 11/4/10 |
| Ceftibuten | CEDAX (ceftibuten) Oral Suspension | Shionogi USA, Inc. | NDA | 50-686 | 11/4/10 |
| Ceftriaxone sodium | Rocephin (ceftriaxone sodium) for Injection | Hoffman-La Roche, Inc. | NDA | 50-585 | 4/12/13 |
| Ceftriaxone for Injection and Dextrose Injection in the Duplex Container, 1g and 2g | Ceftriaxone for Injection and Dextrose Injection in the Duplex Container, 1g and 2g | B.Braun Medical, Inc. | NDA | 50-796 | 3/11/13 |
| Cephalexin Tablets, 500 mg | Cephalexin Tablets, 500 mg | Teva Pharmaceuticals | ANDA | 63-024 | 4/18/12 |
| Ciprofloxacin HCl | Cipro (ciprofloxacin HCl) Tablets | Bayer Healthcare Pharmaceuticals | NDA | 19-537 | 1/30/13 |
| Ciprofloxacin HCl | Cipro I.V. (ciprofloxacin hydrochloride) 1% Solution in Vials | Bayer Healthcare Pharmaceuticals | NDA | 19-847 | 1/30/13 |
| Ciprofloxacin HCl | Cipro (ciprofloxacin hydrochloride) Solution in 5% Dextrose | Bayer Healthcare Pharmaceuticals | NDA | 19-857 | 1/30/13 |
| Ciprofloxacin HCl | Cipro (ciprofloxacin HCl) 5% and 10% Oral Suspension | Bayer Healthcare Pharmaceuticals | NDA | 20-780 | 1/30/13 |
| Ciprofloxacin HCl | Cipro XR (ciprofloxacin HCl) Tablets | Bayer Healthcare Pharmaceuticals | NDA | 21-473 | 1/30/13 |
| Ciprofloxacin HCl | Proquin XR (ciprofloxacin hydrochloride) | Depomed, Inc. | NDA | 21-744 | 12/29/10 |
| Clarithromycin Tablets, USP | BIAXIN Filmtabs (clarithromycin tablets, USP) | Abbott Laboratories | NDA | 50-662 | 5/3/12 |
| Clarithromycin for Oral Suspension, USP | BIAXIN Granules (clarithromycin for oral suspension, USP) | Abbott Laboratories | NDA | 50-698 | 5/3/12 |
| Clarithromycin ER Tablets | BIAXIN XL Filmtabs (clarithromycin ER tablets) | Abbott Laboratories | NDA | 50-775 | 5/3/12 |
| Clindamycin hydrochloride | Cleocin HCl (clindamycin hydrochloride) 75mg, 150 mg, 300 mg capsules | Pfizer, Inc. | NDA | 50-162 | 6/7/11 |
| Clindamycin phosphate with 5% dextrose | Cleocin Phosphate (clindamycin phosphate with 5% dextrose) injection | Pfizer, Inc. | NDA | 50-639 | 6/7/11 |
| Clindamycin phosphate, USP | Cleocin Phosphate (clindamycin phosphate, USP) Injection | Pfizer, Inc. | NDA | 50-441 | 6/7/11 |
| Daptomycin for injection | Cubicin (daptomycin for injection) | Cubist Pharmaceuticals | NDA | 21-572 | 10/3/11 |
| Demeclocycline hydrochloride | Declomycin (demeclocycline hydrochloride) Tablets | CorePharm LLC | NDA | 50-261 | 9/5/12 |
| Doripenem | DORIBAX (doripenem for injection) | Janssen Research and Development LLC | NDA | 22-106 | 1/26/12 |
| Doxycycline monohydrate | Monodox (doxycycline monohydrate) Capsules | Watson Laboratories, Inc. | NDA | 50-641 | 1/11/12 |
| Doxycycline monohydrate | Vibramycin Monohydrate (doxycycline monohydrate) for Oral Suspension | Pfizer, Inc. | NDA | 50-006 | 4/29/13 |
| Doxycycline hyclate capsules, USP | Vibramycin Hyclate (doxycycline hyclate capsules, USP) Capules | Pfizer, Inc. | NDA | 50-007 | 4/29/13 |
| Doxycycline calcium oral suspension, USP | Vibramycin Calcium (doxycycline calcium oral suspension, USP) Syrup | Pfizer, Inc. | NDA | 50-480 | 4/29/13 |
| Doxycycline hyclate tablets, USP | Vibra-Tabs (doxycycline hyclate tablets, USP) Film Coated Tablets | Pfizer, Inc. | NDA | 50-533 | 4/29/13 |
| Ertapenem sodium | Invanz (ertapenem sodium) | Merck, Sharp & Dohme | NDA | 21-337 | 2/17/12 |
| Erythromycin delayed release capsules | ERYC (erythromycin delayed release capsules, USP) 250 mg | Mayne Pharma International | NDA | 50-536 | 3/21/13 |
| Erythromycin ethylsuccinate for oral suspension | E.E.S. Granules (erythromycin ethylsuccinate for oral suspension) EryPed 200, 400, & drops | Abbott Laboratories | NDA | 50-207 | 11/4/10 |
| Erythromycin ethylsuccinate, USP | Ery-Ped Chewable Tablets (erythromycin ethylsuccinate, USP) | Abbott Laboratories | NDA | 50-297 | 11/4/10 |
| Erythromycin lactobionate for injection, USP | Erythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP) vials | Hospira, Inc. | NDA | 50-609 | 6/9/11 |
| Erythromycin particles in tablets | PCE Tablets (erythromycin particles in tablets) Dispertab Tablets | Abbott Laboratories | NDA | 50-611 | 11/4/10 |
| Fosfomycin tromethamine | Monurol (fosfomycin tromethamine) Sachet | Forest Laboratories, Inc. | NDA | 50-717 | 3/15/10 |
| Gemifloxacin mesylate | Factive (gemifloxacin mesylate) Tablet | Cornerstone Therapeutics, Inc. | NDA | 21-158 | 10/18/11 |
| Imipenem and Cilastatin for Injection | Primaxin I.V. (imipenem and cilastatin for injection) | Merck, Sharp & Dohme | NDA | 50-587 | 4/16/12 |
| Levofloxacin | Levaquin (levofloxacin) Tablet | Johnson & Johnson | NDA | 20-634 | 6/10/11 |
| Levofloxacin | Levaquin (levofloxacin) Injection | Johnson & Johnson | NDA | 20-635 | 6/9/11 |
| Levofloxacin | Levaquin (levofloxacin) Oral Solution | Johnson & Johnson | NDA | 21-721 | 6/9/11 |
| Linezolid | Zyvox (linezolid) Tablets | Pfizer Inc. | NDA | 21-130 | 3/15/10 |
| Linezolid | Zyvox (linezolid) IV Injection | Pfizer Inc. | NDA | 21-131 | 3/15/10 |
| Linezolid | Zyvox (linezolid) Oral Suspension | Pfizer Inc. | NDA | 21-132 | 3/15/10 |
| Meropenem for injection | MERREM IV (meropenem for injection) | AstraZeneca UK Limited | NDA | 50-706 | 3/28/13 |
| Methenamine hippurate tablets, USP | Hiprex (methenamine hippurate tablets, USP) | Sanofi Aventis | NDA | 17-681 | 3/15/10 |
| Metronidazole Injection RTU | Metronidazole Injection, USP RTU in Plastic Container | Baxter Healthcare Corporation | NDA | 18-657 | 8/5/11 |
| Micafungin sodium | Mycamine (micafungin sodium) For Injection; IV Infusion Only | Astellas Pharma U.S. Inc. | NDA | 21-506 | 4/19/13 |
| Minocycline | Minocycline Capsules | Teva Pharmaceuticals | ANDA | 63-009 | 1/2/13 |
| 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 | 11/9/11 |
| 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 Oral Solution | Neo-fradin (neomycin sulfate Oral Solution, USP) 125 mg/5 mL | X Gen Pharmaceuticals, Inc. | ANDA | 65-010 | 1/17/12 |
| Nitrofurantoin, Macrocrystalline | Macrodantin Capsules | Almatica Pharma | NDA | 16-620 | 6/6/11 |
| Nitrofurantoin; Nitrofurantoin, Macrocrystalline | Macrobid Capsules | P & G Pharmaceuticals | NDA | 20-064 | 6/6/11 |
| Norfloxacin | Noroxin (norfloxacin) Tablets | Merck, Sharp & Dohme | NDA | 19-384 | 5/27/11 |
| Oxacillin | Oxacillin Injection, USP in Plastic Galaxy Container, PL 2040 | Baxter Healthcare Corporation | NDA | 50-640 | 11/21/12 |
| Penicillin G benzathine & penicillin G Procaine injectable suspension | Bicillin C-R Disposable Syringe for Deep IM Injection Only & Bicillin C-R 900/300 2 mL Syringe | King Pharmaceuticals, Inc. | NDA | 50-141 | 9/5/12 |
| Penicillin G benzathine injectable suspension | Bicillin L-A Disposable Syringe | King Pharmaceuticals, Inc. | NDA | 50-138 | 9/5/12 |
| Penicillin G | Penicillin G Injection, USP in Galaxy Plastic Container | Baxter Healthcare Corporation | NDA | 50-638 | 4/16/12 |
| Penicillin G Sodium | Penicillin G Sodium | Sandoz | ANDA | 65-068 | 10/11/12 |
| Penicillin V Potassium | Penicillin V Potassium | Sandoz | ANDA | 65-068 | 10/11/12 |
| Piperacillin and tazobactam | Zosyn (piperacillin and tazobactam) for Injection, 2.25g, 3.375g and 4.5g Vials & 40.5 Bulk Pharmacy Vials | Wyeth Pharmaceuticals | NDA | 50-684 | 9/28/11 |
| Piperacillin sodium/tazobactam sodium | Zosyn (piperacillin sodium/tazobactam sodium) in Galaxy Containers | Wyeth Pharmaceuticals | NDA | 50-750 | 9/28/11 |
| Polymyxin B Sulfate Injection | Polymyxin B Sulfate Injection | Bedford Laboratories | ANDA | 60-716 | 1/27/12 |
| Quinupristin and dalfopristin | Synercid (quinupristin and dalfopristin for injection) | King Pharmaceuticals, Inc. | NDA | 50-748 | 1/13/12 |
| Spectinomycin hydrochloride | Trobicin (spectinomycin hydrochloride) Sterile Powder | Pfizer, Inc. | NDA | 50-347 | 11/15/11 |
| Streptomycin for Injection, USP, 1 gram | Streptomycin for Injection, USP, 1 gram | X Gen Pharmaceuticals, Inc. | ANDA | 64-210 | 4/30/12 |
| Sulfamethoxazole; Trimethoprim | Bactrim Tablets, USP and Bactrim DS (double strength) Tablets | URL Mutual Pharmaceutical | NDA | 17-377 | 6/28/10 |
| Sulfamethoxazole; Trimethoprim | Sulfamethoxazole; Trimethoprim | Teva Pharmaceuticals | ANDA | 77-612 | 8/13/12 |
| Telithromycin | Ketek (telithromycin) | Sanofi Aventis | NDA | 21-144 | 3/15/10 |
| Ticarcillin disodium & clavulanate potassium (sterile) | Timentin (Sterile ticarcillin disodium & clavulanate potassium) for IV Administration | GlaxoSmithKline | NDA | 50-590 | 6/9/11 |
| Ticarcillin disodium & Clavulante potassium (sterile) | Timentin Galaxy Plastic Container (sterile ticarcillin disodium & Clavulante potassium) | GlaxoSmithKline | NDA | 50-658 | 6/9/11 |
| Tigecycline | Tygacil (tigecycline) | Wyeth Pharmaceuticals | NDA | 21-821 | 3/15/10 |
| Tobramycin for Injection | Tobramycin Injection USP, Pharmacy Bulk Package -1.2 gram | X Gen Pharmaceuticals, Inc. | ANDA | 65-013 | 1/17/12 |
| Tobramycin inhalation solution, USP | TOBI (tobramycin inhalation solution, USP) | Novartis Pharmaceuticals Corp. | NDA | 50-753 | 3/15/10 |
| Tobramycin Sulfate Injection | Tobramycin in 0.9% Sodium Chloride Injection | Hospira, Inc. | ANDA | 63-081 | 12/8/11 |
| Tobramycin Sulfate Injection | Tobramycin Injection USP, Pharmacy Bulk Package -2-grams | Hospira, Inc. | ANDA | 63-116 | 12/8/11 |
| Trimethoprim Tablets, 200 mg | Trimethoprim Tablets, 200 mg | Teva Pharmaceuticals | ANDA | 71-259 | 3/27/12 |
| Vancomycin hydrochloride | Vancocin (vancomycin hydrochloride, USP) Capsules | ViroPharma, Inc. | NDA | 50-606 | 12/14/11 |
| Vancomycin hydrochloride for injection | Vancomycin Hydrochloride for injection, USP, 500 mg vial | Hospira, Inc. | ANDA | 62-911 | 11/30/11 |
| Vancomycin hydrochloride for injection | Vancomycin Hydrochloride for injection, USP, 1 gram vial | Hospira, Inc. | ANDA | 62-912 | 11/30/11 |
| Vancomycin hydrochloride for injection | Vancomycin Hydrochloride for injection, USP, 500 mg ADD-Vantage vial | Hospira, Inc. | ANDA | 62-931 | 11/30/11 |
| Vancomycin hydrochloride for injection | Vancomycin Hydrochloride for injection, USP, 1 gram ADD-Vantage vial | Hospira, Inc. | ANDA | 62-933 | 11/30/11 |
| Vancomycin injection, USP | VANCOCIN HCl (vancomycin injection, USP) in Galaxy Plastic Container | Baxter Healthcare Corporation | NDA | 50-671 | 1/17/12 |
Latest Update: 5/13/2013
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