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

Table Last Updated: January 21, 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 IngredientProduct NameCompany NameType of Appli-cationApplication NumberDate of Most Recent FDA Review of Microbiology Susceptibility Interpretive Criteria*
AmikacinAmikacin Sulfate Injection, 250 mg/mLEurohealth/West-WardANDA63-315/11/16
AmikacinAmikacin Sulfate Solution, Injection 50 mg/mLFresenius Kabi USA LLCANDA20560512/09/15
AmoxicillinAmoxil (amoxicillin) Chewable Tablets  Dr. Reddy's Laboratories NDA50-54209/24/15
AmoxicillinAmoxil (amoxicillin)Tablets-BID Dr. Reddy's Laboratories NDA50-75409/24/15
Amoxicillin Moxatag (amoxicillin extended-release) Tablets, 775 mgVernalis (R&D) LimitedNDA 50-81306/09/15
AmoxicillinAmoxicillin Tablets USP, 500 mg & 875 mgTeva Pharmaceuticals USAANDA 65-05605/02/13
Amoxicillin Amoxil (amoxicillin) Chewable Tablets BID Dr. Reddy's Laboratories NDA50-76109/24/15
Amoxicillin Amoxil (amoxicillin) Oral Suspension - BID Dr. Reddy's Laboratories NDA50-76009/24/15
AmoxicillinAmoxicillin for Suspension USP, 200 mg/5 mL and
400 mg/5 mL
Teva Pharmaceuticals USAANDA65-11911/20/12
Amoxicillin/clavulanate potassiumAUGMENTIN (amox/clavul pot) Tablets 250 & 500 mgGlaxoSmithKlineNDA50-56409/29/11
Amoxicillin/clavulanate potassiumAUGMENTIN (amox/clav pot) Oral Susp 125 & 250 mg/5mLGlaxoSmithKlineNDA50-57509/29/11
Amoxicillin/clavulanate potassiumAmoxicillin and Clavulanate Potassium for Oral Suspension, USP, 200 mg/28.5mg per 5 mL & 400 mg/57 mg per 5 mLTeva Pharmaceutical USAANDA65-0897/25/13
Amoxicillin/clavulanate potassiumAmoxicillin and Clavulanate Potassium Tablets, USP (chewable)
200 mg/28.5mg & 400 mg/57 mg
Teva Pharmaceutical USAANDA65-20507/08/13
Amoxicillin/clavulanate potassiumAUGMENTIN (amox/clav pot) Tablet '875'GlaxoSmithKlineNDA50-72009/29/11
Amoxicillin/clavulanate potassiumAUGMENTIN XR (amoxicillin/clavulate potassium) Tablets, 1000mg/62.5mgDr. Reddy's LaboratoriesNDA50-78508/26/11
Ampicillin sodium/sulfactam sodium Unasyn (ampicillin sodium/sulbactam sodium) for InjectionPfizer, Inc.NDA 50-60803/06/12
Ampicillin sodium/sulfactam sodium Unasyn (ampicillin sodium/sulbactam sodium) for Injection, 2gm/1gm, 1gm/500mgPfizer, Inc.ANDA 62-90104/07/14
Ampicillin SodiumAmpicillin for Injection USP, 125mg, 250mg, 500mg, 1g and 2g per vial and 10g Pharmacy Bulk PackageSandoz, Inc.ANDA61-39507/17/15
Ampicillin TrihydrateAmpicillin Trihydrate Capsule 500 mgDAVA Pharmaceuticals Inc.ANDA62-8829/25/15
Ampicillin TrihydrateAmpicillin Trihydrate Suspension 250 mg/ 5 mLDAVA Pharmaceuticals Inc.ANDA62-9829/25/15
Amphotericin BAmBisome (amphotericin B) liposome for InjectionAstellas Pharma U.S. Inc.NDA50-74003/08/12
AzithromycinZithromax (azithromycin for injection) IVPfizer, Inc.NDA50-73311/16/11
AzithromycinZithromax (azithromycin for oral suspension) Single-Dose PacketPfizer, Inc.NDA50-69311/02/12
AzithromycinZithromax (azithromycin for oral suspension)  Pfizer, Inc.NDA50-71011/02/12
AzithromycinZithromax (azithromycin) 250 mg Tablet  Pfizer, Inc.NDA50-71111/02/12
AzithromycinZithromax (azithromycin) 600 mg Tablet  Pfizer, Inc.NDA50-73011/02/12
AzithromycinZithromax (azithromycin) 500 mg Tablet  Pfizer, Inc.NDA50-78411/02/12
Azithromycin Zithromax (azithromycin) ER Tablet  Pfizer, Inc.NDA50-79710/11/13
Aztreonam AZACTAM (aztreonam for injection, USP)Bristol Myers Squibb CoNDA50-58006/17/13
Aztreonam AZACTAM (aztreonam injection) in GALAXY Plastic Container (PL 2040) for Intravenous UseBristol Myers Squibb CoNDA 50-63206/17/13
CefaclorCefaclor 500 mg Tablet Extended ReleaseTeva Pharmaceutical USAANDA65-05801/22/15
CefaclorCefaclor Capsules, USP, 250 mg and 500 mgWest-Ward Pharmaceutical Corp.ANDA65-35007/24/15
CefaclorCefaclor Oral SuspensionYung Shin Pharmaceutical Industrial Co. Ltd.ANDA65-41210/14/15
Cefadroxil Cefadroxil Tablets, USP, 1000 mgTeva Pharmaceuticals USAANDA62-77404/18/12
Cefadroxil hemihydrateCefadroxil Hemihydrate Oral SuspensionLupinANDA65-39604/18/14
Cefazolin & Dextrose Cefazolin for Injection, USP & Dextrose Injection in the Duplex Container, 1g IntravenousB. Braun Medical, Inc.NDA50-77910/08/15
CefazolinCefazolin for Injection, USP, Pharmacy Bulk Package bags SmartPak 100g & 300gSamson Medical Tech, LLCANDA65-14107/30/13
CefazolinCefazolin for Injection USP, 10 g Pharmacy Bulk
Package
Hospira, Inc.ANDA65-24701/17/13
CefazolinCefazolin Injection, USP, 10 mg/mL and 20 mg/mLBaxter Healthcare CorporationANDA63-00202/29/16
CefazolinCefazolin Sodium,
20 gm/vial
Steri PharmaANDA63-20905/29/16
CefdinirOmnicef (cefdinir) CapsulesAbbott LaboratoriesNDA50-73911/18/15
CefdinirOmnicef (cefdinir) CapsulesAbbott LaboratoriesNDA50-73911/18/15
Cefditoren PivoxilSpectracef (cefditoren pivoxil) 200mg & 400 mg TabletsVansen PharmaNDA 21-22208/06/12
Cefepime HydrochlorideMaxipime (cefepime hydrochloride, USP) for InjectionHospira, Inc.NDA50-67905/01/14
Cefepime HydrochlorideCefepime (cefepime hydrochloride) InjectionBaxter Healthcare CorpNDA50-81705/09/16
CefepimeCefepime for Injection USP and Dextrose Injection USP in Duplex ContainerB. Braun Medical, Inc.NDA50-82106/06/14
CefiximeSuprax (cefixime) Oral Capsule 400 mg Lupin Ltd.NDA20319501/07/16
CefiximeSuprax (cefixime) for Oral Suspension 500 mg/5 mLLupin Ltd.NDA 20209101/07/16
CefiximeSuprax (cefixime) Chewable Tablets, 200 mgLupin Ltd.ANDA 65-38002/16/16
CefiximeCefixime Oral Tablets,
400 mg
Lupin LtdANDA65-1302/16/16
CefobidCefobid (cefoperazone sodium ) IM/IVPfizer IncNDA50-55103/18/15
Cefotaxime sodiumClaforan (cefotaxime sodium) Sterile IV/IMSanofi Aventis US LLCNDA50-54703/03/15
Cefotaxime sodiumClaforan (cefotaxime sodium) InjectionSanofi Aventis US LLCNDA50-59603/03/15
Cefotaxime sodiumCefotaxime Sodium Add Vantage 1 g & 2 g VialSanofi Aventis US LLCANDA62-65903/03/15
Cefoxitin Mefoxin (cefoxitin for injection) 1g/10mL, 2g/20mL & 10g/100mLMylan Institutional LLCNDA50-51705/10/13
Cefoxitin and DextroseCefoxitin and Dextrose in Duplex ContainerB.Braun Medical, Inc.NDA65-21406/05/13
Cefpodoxime ProxetilCefpodoxime Proxetil Tablets USP, 100 mg and 200 mgSandoz Inc.ANDA65-46202/05/14
Cefpodoxime ProxetilCefpodoxime Proxetil Oral Suspension,
100 mg/5 mL
Sandoz Inc.ANDA90-03106/02/14
Ceftaroline fosamilTeflaro (ceftaroline fosamil) for InjectionCerexa, Inc.NDA20032705/29/13
CeftazidimeCeftazidime in Dextrose ContainerB. BraunNDA50-82305/15/15
Ceftazidime - avibactamAVYCAZ (ceftazidime-avibactam) for injectionCerexa, Inc.NDA20649402/25/15
Ceftazidime sodiumFortaz (ceftazidime) Powder for InjectionCovis InjectablesNDA50-57809/24/14
Ceftazidime sodiumFortaz (ceftazidime) in Plastic ContainerCovis InjectablesNDA50-63409/24/14
CeftibutenCEDAX (ceftibuten) CapsulesShionogi USA, Inc.NDA50-68511/04/10
CeftibutenCEDAX (ceftibuten) Oral SuspensionShionogi USA, Inc.NDA50-68611/04/10
Ceftolozane and TazobactamZERBAXA (ceftolozane and tazobactam)Cubist Pharmaceuticals, Inc.NDA20682912/19/14
Ceftriaxone sodiumRocephin (ceftriaxone sodium) for InjectionHoffman-La Roche, Inc.NDA50-58506/30/15
Ceftriaxone sodiumRocephin (ceftriaxone sodium)  for Injection,
500 mg and 1 gm vials
Hoffman-La Roche, Inc.ANDA63-23906/25/15
Ceftriaxone sodiumCeftriaxone for Injection, USP (ceftriaxone powder for injection, 250 mg, 500 mg, 1 & 2 g)Sandoz, Inc.ANDA65-16909/27/13
Ceftriaxone sodiumCeftriaxone for Injection, USP (ceftriaxone powder for injection, 10 g per 100 mL Vial (PBP)Sandoz, Inc.ANDA65-16809/27/13
Ceftriaxone sodiumCeftriaxone for Injection, 1 g & 2 g ADD-Vantage VialsSandoz, Inc.ANDA65-20409/27/13
Ceftriaxone sodiumCeftriaxone Sodium Injectable 1 mg &
500 mg base/vial
Sandoz, Inc.ANDA63-23906/25/15
Ceftriaxone and DextroseCeftriaxone for Injection and Dextrose Injection in the Duplex Container, 1g and 2gB.Braun Medical, Inc.NDA50-79607/09/15
Cefuroxime AxetilCeftin (cefuroxime axetil) TabletGlaxoSmithKlineNDA50-60506/26/15
Cefuroxime AxetilCeftin for Oral Suspension (cefuroxime axetil powder for oral suspension)GlaxoSmithKlineNDA50-67206/26/15
Cefuroxime SodiumZinacef (cefuroxime) Powder for injectionCovis InjectablesNDA50-55809/25/14
Cefuroxime SodiumZinacef (cefuroxime) in Plastic ContainerCovis InjectablesNDA50-64309/25/14
CefuroximeCefuroxime for Injection USP and Dextrose Injection USPB. BraunNDA50-78005/01/15
CephalexinKeflex (cephalexin USP) CapsulesShionogi, Inc.NDA5040510/30/15
Cephalexin Cephalexin Tablets, 500 mgTeva PharmaceuticalsANDA63-02404/18/12
Ciprofloxacin HClCipro (ciprofloxacin HCl) TabletsBayer Healthcare PharmaceuticalsNDA19-53701/30/13
Ciprofloxacin HClCipro I.V. (ciprofloxacin hydrochloride) 1% Solution in VialsBayer Healthcare PharmaceuticalsNDA19-84701/30/13
Ciprofloxacin HClCipro (ciprofloxacin hydrochloride) Solution in 5% DextroseBayer Healthcare PharmaceuticalsNDA19-85701/30/13
Ciprofloxacin HClCipro (ciprofloxacin HCl)  5% and 10% Oral SuspensionBayer Healthcare PharmaceuticalsNDA20-78001/30/13
Ciprofloxacin HClCipro XR (ciprofloxacin HCl) TabletsBayer Healthcare PharmaceuticalsNDA21-47301/30/15
Ciprofloxacin HClCiprofloxacin Extended Release Tablets
500 mg and 1000 mg
Mylan Pharms Inc.ANDA78-1838/14/13
Ciprofloxacin HClProquin XR (ciprofloxacin hydrochloride)Depomed, Inc.NDA21-74412/29/10
Clarithromycin BIAXIN Filmtabs (clarithromycin tablets, USP)Abbott LaboratoriesNDA50-66205/03/12
Clarithromycin BIAXIN Granules (clarithromycin for oral suspension, USP)Abbott LaboratoriesNDA50-69805/03/12
Clarithromycin BIAXIN XL Filmtabs (clarithromycin ER tablets)Abbott LaboratoriesNDA50-77505/03/12
Clindamycin hydrochlorideCleocin HCl (clindamycin hydrochloride) 75mg, 150 mg, 300 mg capsulesPfizer, Inc. NDA50-162 03/23/16
Clindamycin phosphate and dextroseCleocin Phosphate (clindamycin phosphate with 5% dextrose) injectionPfizer, Inc.NDA50-63903/23/16
Clindamycin phosphateCleocin Phosphate (clindamycin phosphate, USP) Injection Pfizer, Inc.NDA50-44103/23/16
Dalbavancin HydrochlorideDalvance (dalbavancin) for Injection, for intravenous useDurata Therapeutics, Inc.NDA21-88305/23/14
Daptomycin Cubicin (daptomycin for injection)Cubist PharmaceuticalsNDA21-57210/03/11
Demeclocycline hydrochlorideDeclomycin (demeclocycline hydrochloride) TabletsCorePharm LLCNDA 50-26109/05/12
Demeclocycline hydrochlorideDemeclocycline hydrochloride Tablets USP, 150 mg and 300 mgAmneal PharmANDA65-42502/05/13
DicloxacillinDicloxacillin Sodium Capsules, USP, 500 mgSandoz, Inc.ANDA61-45401/26/16
DoripenemDORIBAX (doripenem for injection)Janssen Research and Development LLCNDA22-10601/26/12
DoxycyclineDOXY 100 & 200TM (Doxycycline for Injection USP, 100 mg and 200 mg
per vial).
Fresenius Kabi USA, LLCANDA62-47501/28/14
DoxycyclineDoxycycline Capsules USP, 50 mg, 75 mg, 100 mg, and 150 mgPar Pharmaceuticals, Inc.ANDA65-05507/10/14
DoxycyclineDoxycycline Tablets 50, 75, 100, & 150 mgPar Pharmaceuticals, Inc.ANDA65-07012/20/15
Doxycycline monohydrateMonodox (doxycycline monohydrate) CapsulesWatson Laboratories, Inc.NDA50-64101/11/12
Doxycycline monohydrateVibramycin Monohydrate (doxycycline monohydrate) for Oral SuspensionPfizer, Inc.NDA50-00609/12/14
Doxycycline hyclateVibramycin Hyclate (doxycycline hyclate capsules, USP) CapsulesPfizer, Inc.NDA 50-00709/12/14
Doxycycline calcium Vibramycin Calcium (doxycycline calcium oral suspension, USP) SyrupPfizer, Inc.NDA50-48009/12/14
Doxycycline hyclate Vibra-Tabs (doxycycline hyclate tablets, USP) Film Coated TabletsPfizer, Inc.NDA 50-53309/12/14
Doxycycline hyclateDoryx (doxycycline hyclate delayed release tablets) Tablets 80, 100, 150 & 200 mgMayne Pharma InternationalNDA50-79504/11/13
Doxycycline hyclateDoxycycline Hyclate Tablets, USP 100 mgWest-Ward Pharmaceutical CorpANDA65-09506/25/14
Doxycycline hyclateDoxycycline Hyclate Delayed-Release Capsules, 75 mg and 100 mgMedicis Pharmaceutical CorporationANDA65-28112/21/15
Doxycycline hyclateDoxycycline Hyclate InjectionFresenius Kabi USA LLCANDA62-47501/26/16
Ertapenem sodiumInvanz (ertapenem sodium)Merck, Sharp & DohmeNDA21-33702/17/12
Erythromycin ERYC  (erythromycin delayed release capsules, USP) 250 mgMayne Pharma InternationalNDA 50-53603/21/13
ErythromycinErythromycin Tablets USP, 250 mg and 500 mgArbor Pharmaceuticals, Inc.ANDA61-62112/04/13
ErythromycinERY-TAB (erythromycin delayed-release tablets, USP) Enteric-Coated, 250
mg, 333 mg, and 500 mg.
Arbor Pharmaceuticals, IncANDA62-29812/04/13
Erythromycin ethylsuccinate E.E.S. Granules (erythromycin ethylsuccinate for oral suspension) EryPed 200, 400, & dropsAbbott LaboratoriesNDA50-20711/04/10
Erythromycin ethylsuccinateEry-Ped Chewable Tablets (erythromycin ethylsuccinate, USP)Abbott LaboratoriesNDA50-29711/04/10
Erythromycin ethylsuccinateEES (erythromycin ethylsuccinate oral suspension, USP)
Liquid 200 mg/5 mL and 400 mg/5 mL
Arbor Pharmaceuticals, Inc.ANDA61-63910/31/13
Erythromycin ethylsuccinateErythromycin Ethylsuccinate Tablets USP, 400 mg.Arbor Pharmaceuticals, Inc.ANDA61-90412/04/13
Erythromycin ethylsuccinateEES 400 Film-coated Tablets (erythromycin ethylsuccinate tablets, USP) 400 mgArbor Pharmaceuticals, IncANDA61-90510/31/13
Erythromycin Ethylsuccinate and Sulfisoxazole AcetylErythromycin ethylsuccinate and sulfisoxazole acetyl granule, for suspension, oral 200 mg base/5 mLBarr Laboratories Inc.ANDA62-75912/16/15
Erythromycin lactobionateErythrocin Lactobionate-I.V. (erythromycin lactobionate for injection, USP)  vialsHospira, Inc.NDA50-60906/09/11
Erythromycin lactobionateErythromycin Lactobionate I.V. (erythromycin lactobioinate for injection, USP) 500 mg and 1 g ADD-Vantage VialsHospira, Inc.ANDA62-63808/26/13
Erythromycin particles PCE Tablets (erythromycin particles in tablets) Dispertab TabletsAbbott LaboratoriesNDA50-61111/04/10
Erythromycin stearateErythrocin Stearate (erythromycin stearate tablets, USP) Film-coated Tablets, 250 mgArbor Pharmaceuticals, Inc.ANDA60-35912/04/13
Fosfomycin tromethamineMonurol (fosfomycin tromethamine) SachetForest Laboratories, Inc.NDA50-71703/15/10
Gemifloxacin mesylateFactive (gemifloxacin mesylate) TabletCornerstone Therapeutics, Inc.NDA21-15810/18/11
Gentamicin SulfateGentamicin Sulfate in 0.9% Sodium Chloride Injection in Plastic ContainerBaxter Healthcare CorporationANDA62-37312/11/15
Gentamicin SulfateGentamicin Sulfate InjectionFresenius Kabi USA LLCANDA62-36603/07/14
Imipenem and CilastatinPrimaxin I.V. (imipenem and cilastatin for injection)Merck, Sharp & DohmeNDA50-58704/16/12
Kanamycin InjectionKanamycin Injection USP,
1 gm per 3 mL
Fresenius Kabi, USA, LLCANDA65-11107/15/15
LevofloxacinLevaquin (levofloxacin) TabletJohnson & JohnsonNDA20-63406/10/11
LevofloxacinLevaquin (levofloxacin) InjectionJohnson & JohnsonNDA20-63506/09/11
LevofloxacinLevaquin (levofloxacin) Oral SolutionJohnson & JohnsonNDA21-72106/09/11
Lincomycin hydrochlorideLincocin (lincomycin hydrochloride Injection, USP) Sterile SolutionPfizer Inc.NDA50-31710/15/14
LinezolidZyvox (linezolid) TabletsPfizer Inc.NDA21-13006/05/15
LinezolidZyvox (linezolid) IV InjectionPfizer Inc.NDA21-13106/05/15
LinezolidZyvox (linezolid) Oral SuspensionPfizer Inc.NDA21-13206/05/15
Meropenem MERREM IV (meropenem for injection)AstraZeneca UK LimitedNDA50-70603/28/13
Methenamine hippurate Hiprex (methenamine hippurate tablets, USP)Sanofi AventisNDA17-68103/15/10
Metronidazole  Metronidazole Injection, USP RTU in Plastic ContainerBaxter Healthcare CorporationNDA18-65707/13/15
Metronidazole  Metronidazole Injection USP (5 mg/mL) in PAB Plastic ContainerB. BraunNDA18-90007/13/15
Metronidazole  Metronidazole Injection USP, 500 mg (5 mg/mL) in Flexible ContainersHospiraNDA18-89007/13/15
Metronidazole  Flagyl (metronidazole) TabletsGD Searle LLCNDA12-62307/13/15
Metronidazole 
hydrochloride 
Flagyl (metronidazole hydrochloride) IntravenousGD Searle LLCNDA18-35307/13/15
Metronidazole  Flagyl (metronidazole) CapsulesGD Searle LLCNDA20-33407/13/15
Metronidazole  Flagyl (metronidazole) Extended Release TabletsGD Searle LLCNDA20-86807/13/15
Micafungin sodiumMycamine (micafungin sodium) For Injection; IV Infusion OnlyAstellas Pharma U.S. Inc.NDA21-50604/19/13
Minocycline Minocycline CapsulesTeva Pharmaceuticals ANDA63-00901/02/13
Minocycline HydrochlorideDynacin (minocycline hydrochloride tablets, USP) 50 mg, 75 mg and 100 mgPar Pharmaceuticals Inc.ANDA65-13105/11/12
Moxifloxacin hydrochlorideAvelox (moxifloxacin hydrochloride) TabletsBayer HealthCare Pharmaceuticals, Inc.NDA21-08510/18/11
Moxifloxacin hydrochlorideAvelox (moxifloxacin hydrochloride) IVBayer HealthCare Pharmaceuticals, Inc.NDA21-27710/18/11
NafcillinNafcillin Injection, USP in Plastic Galaxy Container, PL 2040Baxter Healthcare CorporationNDA50-65511/09/11
NafcillinNafcillin for Injection, USPSandoz, IncANDA62-52701/04/16
NafcillinNafcillin for Injection, USPSandoz, IncANDA62-73201/13/16
Nalidixic acidNegram (nalidixic acid)Sanofi AventisNDA14-21411/28/12
Neomycin Sulfate Neomycin Sulfate Tablet, USP, 500 mgTeva PharmaceuticalsANDA60-30411/30/11
Neomycin Sulfate Neo-fradin (neomycin sulfate Oral Solution, USP) 125 mg/5 mLX Gen Pharmaceuticals, Inc.ANDA65-01001/17/12
Nitrofurantoin Furadantin (nitrofurantoin) Oral SuspensionShionogi, Inc.NDA9-17511/04/13
Nitrofurantoin, MacrocrystallineMacrodantin CapsulesAlmatica PharmaNDA16-62006/06/11
Nitrofurantoin; Nitrofurantoin, MacrocrystallineMacrobid CapsulesP & G PharmaceuticalsNDA20-06406/06/11
NorfloxacinNoroxin (norfloxacin) TabletsMerck, Sharp & DohmeNDA19-38405/27/11
OfloxacinOfloxacin Tablets
200 mg, 300 mg &
400 mg
Teva Pharmaceuticals USAANDA76-18204/10/14
Oritavancin diphosphateOrbactiv (oritavancin diphosphate) Lyophilized Powder for Injection, 400 mg/vialThe Medicines CompanyNDA20633408/06/14
OxacillinOxacillin Injection, USP in Plastic Galaxy Container, PL 2040Baxter Healthcare CorporationNDA50-64001/06/15
OxacillinOxacillin for Injection, USPSandoz, Inc.ANDA61-49004/11/16
Penicillin G benzathine & penicillin G Procaine Bicillin C-R Disposable Syringe for Deep IM Injection Only & Bicillin C-R 900/300 2 mL SyringeKing Pharmaceuticals, Inc.NDA50-14110/13/15
Penicillin G benzathine Bicillin L-A (pen G Benzathine Inj Solution) Disposable SyringeKing Pharmaceuticals, Inc.NDA 50-13810/13/15
Penicillin GPenicillin G Injection, USP in Galaxy Plastic Container Baxter Healthcare CorporationNDA50-63804/16/12
Penicillin GPenicillin G Procaine Injection, Suspension
1 mL and 2 mL Syringe
King Pharmaceuticals, Inc.ANDA60-10112/16/15
Penicillin G SodiumPenicillin G SodiumSandozANDA65-06810/11/12
Penicillin V PotassiumPenicillin V PotassiumSandozANDA64-07110/11/12
Penicillin V PotassiumPenicillin 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.ANDA60-45607/16/14
Piperacillin Sodium /Tazobactam Zosyn (piperacillin and tazobactam) for Injection, 2.25g, 3.375g and 4.5g Vials & 40.5 Bulk Pharmacy VialsPfizer Inc.NDA50-68409/06/13
Piperacillin Sodium/Tazobactam SodiumZosyn (piperacillin sodium/tazobactam sodium) in Galaxy ContainersPfizer Inc.NDA50-75009/06/13
Piperacillin SodiumPiperacillin Sodium Injectable, 40 gm base/vial IstitutoBiochimico ItalianoANDA65-15703/05/16
Piperacillin SodiumPiperacillin Sodium Injectable, 2, 3, & 4 gm base/vialIstituto Biochimico ItalianoANDA65-11403/05/16
Polymyxin B SulfatePolymyxin B Sulfate InjectionBedford LaboratoriesANDA60-71601/27/12
Quinupristin and dalfopristinSynercid (quinupristin and dalfopristin for injection)King Pharmaceuticals, Inc.NDA50-74801/13/12
Spectinomycin hydrochlorideTrobicin (spectinomycin hydrochloride) Sterile Powder Pfizer, Inc. NDA50-34711/15/11
Streptomycin Streptomycin for Injection, USP, 1 gramX Gen Pharmaceuticals, Inc.ANDA64-21004/30/12
Sulfamethoxazole; TrimethoprimBactrim Tablets, USP and Bactrim DS (double strength) TabletsURL Mutual Pharmaceutical NDA17-37706/28/10
Sulfamethoxazole; TrimethoprimSulfamethoxazole & Trimethoprim Injection 80 & 16 mg/mLTeva Pharmaceuticals USAANDA73-30304/29/13
Sulfamethoxazole and TrimethoprimSulfamethoxazole & Trimethoprim Oral Suspension, USP, 200 mg/40 mg per 5mLHi Tech Pharmacal CoANDA74-65012/15/11
Tedizolid PhosphateSivextro (tedizolid phosphate) TabletCubist Pharmaceuticals, Inc.NDA20543506/20/14
Tedizolid PhosphateSivextro (tedizolid phosphate) InjectionCubist Pharmaceuticals, Inc.NDA20543606/20/14
TelavancinVibativ (telavancin) for Injection 250 & 750 mgTheravance, Inc.NDA22-11002/07/14
TelithromycinKetek (telithromycin) TabletSanofi AventisNDA21-14403/09/15

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

TrimethoprimTrimethoprim Tablets, 100 mgTeva PharmaceuticalsNDA18-67906/13/16

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

VancomycinVancomycin hydrochloride injectionAPP/FreseniusANDA62-66302/16/16

Latest Update: 06/22/2016

 

Page Last Updated: 06/22/2016
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