Application 202949
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 20MG BASE | No | No |
| 002 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 30MG BASE | No | No |
| 003 | DULOXETINE HYDROCHLORIDE | DULOXETINE HYDROCHLORIDE | CAPSULE, DELAYED REL PELLETS;ORAL | EQ 60MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 46708-128 | Duloxetine Hydrochloride | Duloxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-129 | Duloxetine Hydrochloride | Duloxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-130 | Duloxetine Hydrochloride | Duloxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-278 | DULOXETINE HYDROCHLORIDE | Duloxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-278 | DULOXETINE HYDROCHLORIDE | Duloxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-279 | DULOXETINE HYDROCHLORIDE | Duloxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-279 | DULOXETINE HYDROCHLORIDE | Duloxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-280 | DULOXETINE HYDROCHLORIDE | Duloxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-280 | DULOXETINE HYDROCHLORIDE | Duloxetine | Alembic Pharmaceuticals Limited | ANDA | Current |