Application 208698
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 10MG BASE | No | No |
| 002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | TABLET;ORAL | EQ 20MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-242 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-242 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-243 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-243 | Fluoxetine Hydrochloride | Fluoxetine Hydrochloride | Alembic Pharmaceuticals Limited | ANDA | Current |
| 55700-617 | Fluoxetine | Fluoxetine | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 62332-242 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-242 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-242 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-242 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-243 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-243 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-243 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-243 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |