FDA.reportPublic FDA data

Application 077899

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL30MGNoNo
002NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL60MGNoNo
003NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL90MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6544NifedipineNifedipineMajor PharmaceuticalsANDACurrent
0904-6545NifedipineNifedipineMajor PharmaceuticalsANDACurrent
10370-677NifedipineNifedipinePar Pharmaceutical, Inc.ANDACurrent
10370-678NifedipineNifedipinePar Pharmaceutical, Inc.ANDACurrent
10370-679NifedipineNifedipinePar Pharmaceutical, Inc.ANDACurrent
21695-909NifedipineNifedipineRebel Distributors CorpANDACurrent
45963-152NifedipineNifedipineActavis Pharma, Inc.ANDACurrent
45963-152NifedipineNifedipineActavis Pharma, Inc.ANDACurrent
49884-677NifedipineNifedipinePar Pharmaceutical, Inc.ANDACurrent
49884-678NifedipineNifedipinePar Pharmaceutical, Inc.ANDACurrent
49884-679NifedipineNifedipinePar Pharmaceutical, Inc.ANDACurrent
49999-476NifedipineNifedipineLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-3034NifedipineNifedipineA-S Medication SolutionsANDACurrent
50090-3034NifedipineNifedipineA-S Medication SolutionsANDACurrent
50090-3035NifedipineNifedipineA-S Medication SolutionsANDACurrent
53808-0387NifedipineNIFEDIPINEState of Florida DOH Central PharmacyANDACurrent
53808-0389NifedipineNIFEDIPINEState of Florida DOH Central PharmacyANDACurrent
53808-0898NifedipineNifedipineState of Florida DOH Central PharmacyANDACurrent
60687-269NifedipineNifedipineAmerican Health PackagingANDACurrent