Application 216967
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MESALAMINE | MESALAMINE | CAPSULE, EXTENDED RELEASE;ORAL | 375MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-724 | MESALAMINE | MESALAMINE | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-724 | MESALAMINE | MESALAMINE | Alembic Pharmaceuticals Inc. | ANDA | Current |