FDA.report

Application 077127

Type
ANDA
Sponsor
OSMOTICA PHARM US

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL30MGNoNo
002NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL60MGNoNo
003NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL90MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-908nifedipinenifedipineRebel Distributors CorpANDACurrent
42254-095NifedipineNifedipineRebel Distributors CorpANDACurrent
49999-357NifedipineNifedipineLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-2920NifedipineNifedipineA-S Medication SolutionsANDACurrent
50268-597NifedipineNifedipineAvPAKANDACurrent
50268-597NifedipineNifedipineAvPAKANDACurrent
50268-597NifedipineNifedipineAvPAKANDACurrent
50268-597NifedipineNifedipineAvPAKANDACurrent
50268-598NifedipineNifedipineAvPAKANDACurrent
50268-598NifedipineNifedipineAvPAKANDACurrent
50268-598NifedipineNifedipineAvPAKANDACurrent
50268-598NifedipineNifedipineAvPAKANDACurrent
50436-4068NifedipineNifedipineUnit Dose ServicesANDACurrent
50436-4069NifedipineNifedipineUnit Dose ServicesANDACurrent
53808-0621NifedipineNifedipineState of Florida DOH Central PharmacyANDACurrent
53808-0693NifedipineNifedipineState of Florida DOH Central PharmacyANDACurrent
54458-948NIFEDIPINENIFEDIPINEInternational Laboratories, LLCANDACurrent
54458-950NIFEDIPINENIFEDIPINEInternational Laboratories, LLCANDACurrent
55154-4690NifedipineNifedipineCardinal Health 107, LLCANDACurrent
55154-4690NifedipineNifedipineCardinal HealthANDACurrent
55154-4690NifedipineNifedipineCardinal HealthANDACurrent
55154-4690NifedipineNifedipineCardinal HealthANDACurrent
55154-4690NifedipineNifedipineCardinal HealthANDACurrent
55154-8177NifedipineNifedipineCardinal Health 107, LLCANDACurrent
55154-8177NifedipineNifedipineCardinal HealthANDACurrent
55154-8177NifedipineNifedipineCardinal HealthANDACurrent
55154-8177NifedipineNifedipineCardinal HealthANDACurrent
55154-8177NifedipineNifedipineCardinal HealthANDACurrent
55289-798NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-798NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-798NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-798NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-798NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55700-397NifedipineNifedipineLake Erie Medical DBA Quality Care Products LLCANDACurrent
62175-260NifedipineNifedipineKremers Urban Pharmaceuticals Inc.ANDACurrent
62175-260NifedipineNifedipineKremers Urban PharmaceutiANDACurrent
62175-261NifedipineNifedipineKremers Urban Pharmaceuticals Inc.ANDACurrent
62175-261NifedipineNifedipineKremers Urban PharmaceutiANDACurrent
63187-875NifedipineNifedipineProficient Rx LPANDACurrent
63187-875NifedipineNifedipineProficient Rx LPANDACurrent
68071-3036NifedipineNifedipineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3364NifedipineNifedipineNuCare Pharmaceuticals,Inc.ANDACurrent
68084-597NifedipineNifedipineAmerican Health PackagingANDACurrent
68084-597NifedipineNifedipineAmerican Health PackagingANDACurrent
68084-597NifedipineNifedipineAmerican Health PackagingANDACurrent
68084-597NifedipineNifedipineAmerican Health PackagingANDACurrent
68084-598NifedipineNifedipineAmerican Health PackagingANDACurrent
68084-598NifedipineNifedipineAmerican Health PackagingANDACurrent
68084-598NifedipineNifedipineAmerican Health PackagingANDACurrent
68084-598NifedipineNifedipineAmerican Health PackagingANDACurrent
68084-603NifedipineNifedipineAmerican Health PackagingANDACurrent
68084-603NifedipineNifedipineAmerican Health PackagingANDACurrent
68645-512NifedipineNifedipineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-512NifedipineNifedipineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-512NifedipineNifedipineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-512NifedipineNifedipineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-513NifedipineNifedipineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-513NifedipineNifedipineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-513NifedipineNifedipineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-513NifedipineNifedipineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-603NifedipineNifedipineLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-604NifedipineNifedipineLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-0167NifedipineNifedipinePreferred Pharmaceuticals, Inc.ANDACurrent
70518-0792NifedipineNifedipineREMEDYREPACK INC.ANDACurrent
70518-0792NifedipineNifedipineREMEDYREPACK INC.ANDACurrent