Application 211935
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 25MG | No | No |
| 002 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 50MG | No | No |
| 003 | NITROFURANTOIN | NITROFURANTOIN, MACROCRYSTALLINE | CAPSULE;ORAL | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-389 | NITROFURANTOIN | NITROFURANTOIN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-390 | NITROFURANTOIN | NITROFURANTOIN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-391 | NITROFURANTOIN | NITROFURANTOIN | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-389 | NITROFURANTOIN | NITROFURANTOIN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-389 | NITROFURANTOIN | NITROFURANTOIN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-390 | NITROFURANTOIN | NITROFURANTOIN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-390 | NITROFURANTOIN | NITROFURANTOIN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-391 | NITROFURANTOIN | NITROFURANTOIN | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-391 | NITROFURANTOIN | NITROFURANTOIN | Alembic Pharmaceuticals Inc. | ANDA | Current |