FDA.reportPublic FDA data

Application 076095

Type
ANDA
Sponsor
ANI PHARMS 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
10135-745MisoprostolMisoprostolMarlex Pharmaceuticals, Inc.ANDACurrent
10135-746MisoprostolMisoprostolMarlex Pharmaceuticals, Inc.ANDACurrent
43393-023MisoprostolMisoprostolGenBioPro, Inc.ANDACurrent
68071-2904MisoprostolMisoprostolNuCare Pharmaceuticals,Inc.ANDACurrent
70954-443MisoprostolMisoprostolNovitium Pharma LLCANDACurrent
70954-443MisoprostolMisoprostolNovitium Pharma LLCANDACurrent
70954-444MisoprostolMisoprostolNovitium Pharma LLCANDACurrent
70954-444MisoprostolMisoprostolNovitium Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
23801ORIG2005-07-29
22535ORIG2005-07-22
31075ORIG2002-07-10