FDA.report

Application 065435

Type
ANDA
Sponsor
AUROBINDO PHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMTABLET;ORALEQ 250MG BASENoNo
002PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMTABLET;ORALEQ 500MG BASENoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-075Penicillin V PotassiumPenicillin V PotassiumBlenheim Pharmacal, Inc.ANDACurrent
16714-234Penicillin V PotassiumPenicillin V PotassiumNorthStar Rx LLCANDACurrent
16714-234Penicillin V PotassiumPenicillin V PotassiumNorthStar Rx LLCANDACurrent
16714-234Penicillin V PotassiumPenicillin V PotassiumNorthStar Rx LLCANDACurrent
16714-235Penicillin V PotassiumPenicillin V PotassiumNorthStar Rx LLCANDACurrent
16714-235Penicillin V PotassiumPenicillin V PotassiumNorthStar Rx LLCANDACurrent
16714-235Penicillin V PotassiumPenicillin V PotassiumNorthStar Rx LLCANDACurrent
42708-098Penicillin V PotassiumPenicillin V PotassiumQPharma IncANDACurrent
42708-098Penicillin V PotassiumPenicillin V PotassiumQPharma IncANDACurrent
43063-557Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-557Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-557Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-557Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-557Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-576Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-576Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-576Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-576Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-576Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-614Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-614Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-614Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-614Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-614Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-622Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-622Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-622Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-622Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-622Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-680Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-680Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-680Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-680Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-680Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-704Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, InANDACurrent
43063-704Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-704Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-704Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-704Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-704Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-704Penicillin V PotassiumPenicillin V PotassiumPD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-1610Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-1612Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-2286Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-2286Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-2287Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-2287Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3425Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-3506Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-4651Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-4652Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-4652Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-5543Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50090-5543Penicillin V PotassiumPenicillin V PotassiumA-S Medication SolutionsANDACurrent
50436-0040Penicillin V PotassiumPenicillin V PotassiumUnit Dose ServicesANDACurrent
53002-2010Penicillin V PotassiumPenicillin V PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-2010Penicillin V PotassiumPenicillin V PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-2020Penicillin V PotassiumPenicillin V PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
53002-2020Penicillin V PotassiumPenicillin V PotassiumRPK Pharmaceuticals, Inc.ANDACurrent
55700-230Penicillin V PotassiumPenicillin V PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-230Penicillin V PotassiumPenicillin V PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-440Penicillin V PotassiumPenicillin V PotassiumLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-826Penicillin V PotassiumPenicillin V PotassiumQuality Care Products, LLCANDACurrent
55700-826Penicillin V PotassiumPenicillin V PotassiumQuality Care Products, LLCANDACurrent
55700-826Penicillin V PotassiumPenicillin V PotassiumQuality Care Products, LLCANDACurrent
55700-826Penicillin V PotassiumPenicillin V PotassiumQuality Care Products, LLCANDACurrent
57237-040Penicillin V PotassiumPenicillin V PotassiumRising Health, LLCANDACurrent
57237-040Penicillin V PotassiumPenicillin V PotassiumRising Health, LLCANDACurrent
57237-040Penicillin V PotassiumPenicillin V PotassiumRising Health, LLCANDACurrent
57237-041Penicillin V PotassiumPenicillin V PotassiumRising Health, LLCANDACurrent
57237-041Penicillin V PotassiumPenicillin V PotassiumRising Health, LLCANDACurrent
57237-041Penicillin V PotassiumPenicillin V PotassiumRising Health, LLCANDACurrent
61919-649PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMDirectRXANDACurrent
61919-649PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMDirect_RxANDACurrent
61919-649PENICILLIN V POTASSIUMPENICILLIN V POTASSIUMDirectRXANDACurrent
63187-676Penicillin V PotassiumPenicillin V PotassiumProficient Rx LPANDACurrent
63187-676Penicillin V PotassiumPenicillin V PotassiumProficient Rx LPANDACurrent
63187-756Penicillin V PotassiumPenicillin V PotassiumProficient Rx LPANDACurrent
63187-756Penicillin V PotassiumPenicillin V PotassiumProficient Rx LPANDACurrent
63187-926Penicillin V PotassiumPenicillin V PotassiumProficient Rx LPANDACurrent