FDA.reportPublic FDA data

Application 091667

Type
ANDA
Sponsor
NOVEL LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MISOPROSTOLMISOPROSTOLTABLET;ORAL0.1MGNoNo
002MISOPROSTOLMISOPROSTOLTABLET;ORAL0.2MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0218MisoprostolMisoprostolKAISER FOUNDATION HOSPITALSANDACurrent
0904-6806MisoprostolMisoprostolMajor PharmaceuticalsANDACurrent
0904-6807MisoprostolMisoprostolMajor PharmaceuticalsANDACurrent
33261-076MisoprostolMisoprostolAidarex Pharmaceuticals LLCANDACurrent
33261-754MisoprostolMisoprostolAidarex Pharmaceuticals LLCANDACurrent
40032-160MisoprostolMisoprostolNovel Laboratories, Inc.ANDACurrent
40032-160MisoprostolMisoprostolNovel Laboratories, Inc.ANDACurrent
40032-160MisoprostolMisoprostolNovel Laboratories, Inc.ANDACurrent
40032-161MisoprostolMisoprostolNovel Laboratories, Inc.ANDACurrent
40032-161MisoprostolMisoprostolNovel Laboratories, Inc.ANDACurrent
40032-161MisoprostolMisoprostolNovel Laboratories, Inc.ANDACurrent
43063-707MisoprostolMisoprostolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-707MisoprostolMisoprostolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-707MisoprostolMisoprostolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-707MisoprostolMisoprostolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-707MisoprostolMisoprostolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-707MisoprostolMisoprostolPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-707MisoprostolMisoprostolPD-Rx Pharmaceuticals, InANDACurrent
43386-160MisoprostolMisoprostolLupin Pharmaceuticals,Inc.ANDACurrent
43386-160MisoprostolMisoprostolLupin Pharmaceuticals,Inc.ANDACurrent
43386-160MisoprostolMisoprostolLupin Pharmaceuticals,Inc.ANDACurrent
43386-161MisoprostolMisoprostolLupin Pharmaceuticals,Inc.ANDACurrent
43386-161MisoprostolMisoprostolLupin Pharmaceuticals,Inc.ANDACurrent
43386-161MisoprostolMisoprostolLupin Pharmaceuticals,Inc.ANDACurrent
43393-022MisoprostolMisoprostolGenBioPro, Inc.ANDACurrent
43393-022MisoprostolMisoprostolGenBioPro, Inc.ANDACurrent
43393-203MisoprostolMisoprostolGenBioPro IncANDACurrent
50436-3172MisoprostolMisoprostolUnit Dose ServicesANDACurrent
54348-148MisoprostolMISOPROSTOLPharmPak, Inc.ANDACurrent
54348-148MisoprostolMISOPROSTOLPharmPak, Inc.ANDACurrent
55154-4998MisoprostolMisoprostolCardinal HealthANDACurrent
55154-4998MisoprostolMisoprostolCardinal HealthANDACurrent
63629-7929MisoprostolMisoprostolBryant Ranch PrepackANDACurrent
63629-7929MisoprostolMisoprostolBryant Ranch PrepackANDACurrent
63629-7929MisoprostolMisoprostolBryant Ranch PrepackANDACurrent
63704-008MisoprostolMisoprostolPharmacist Pharmaceutical, LLCANDACurrent
64205-161MisoprostolMisoprostolReadyMedsANDACurrent
68071-4843MisoprostolMisoprostolNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4843MisoprostolMisoprostolNuCare Pharmaceuticals,Inc.ANDACurrent
68084-040MisoprostolMisoprostolAmerican Health PackagingANDACurrent
68084-040MisoprostolMisoprostolAmerican Health PackagingANDACurrent
68084-040MisoprostolMisoprostolAmerican Health PackagingANDACurrent
68084-040MisoprostolMisoprostolAmerican Health PackagingANDACurrent
68084-040MisoprostolMisoprostolAmerican Health PackagingANDACurrent
68084-040MisoprostolMisoprostolAmerican Health PackagingANDACurrent
68084-041MisoprostolMisoprostolAmerican Health PackagingANDACurrent
68084-041MisoprostolMisoprostolAmerican Health PackagingANDACurrent
68084-041MisoprostolMisoprostolAmerican Health PackagingANDACurrent
68084-041MisoprostolMisoprostolAmerican Health PackagingANDACurrent
68084-041MisoprostolMisoprostolAmerican Health PackagingANDACurrent
68084-041MisoprostolMisoprostolAmerican Health PackagingANDACurrent
69189-0161MisoprostolMisoprostolAvera McKennan HospitalANDACurrent
71335-0460MisoprostolMisoprostolBryant Ranch PrepackANDACurrent
71335-0460MisoprostolMisoprostolBryant Ranch PrepackANDACurrent
71335-0460MisoprostolMisoprostolBryant Ranch PrepackANDACurrent
72789-121MisoprostolMisoprostolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-121MisoprostolMisoprostolPD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-121MisoprostolMisoprostolPD-Rx Pharmaceuticals, Inc.ANDACurrent