Application 090223
- 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 | CAPSULE;ORAL | EQ 10MG BASE | No | No |
| 002 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 20MG BASE | No | No |
| 003 | FLUOXETINE HYDROCHLORIDE | FLUOXETINE HYDROCHLORIDE | CAPSULE;ORAL | EQ 40MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 16714-351 | Fluoxetine | Fluoxetine | NorthStar RxLLC | ANDA | Current |
| 16714-352 | Fluoxetine | Fluoxetine | NorthStar RxLLC | ANDA | Current |
| 16714-353 | Fluoxetine | Fluoxetine | NorthStar RxLLC | ANDA | Current |
| 43063-839 | Fluoxetine | Fluoxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-839 | Fluoxetine | Fluoxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-839 | Fluoxetine | Fluoxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-839 | Fluoxetine | Fluoxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-839 | Fluoxetine | Fluoxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-839 | Fluoxetine | Fluoxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-839 | Fluoxetine | Fluoxetine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 46708-271 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-271 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-272 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-272 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-273 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-273 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Limited | ANDA | Current |
| 61919-253 | FLUOXETINE | FLUOXETINE | DIRECT RX | ANDA | Current |
| 61919-253 | FLUOXETINE | FLUOXETINE | DIRECT RX | ANDA | Current |
| 62332-022 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-022 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-022 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-022 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-022 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-022 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-023 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-023 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-023 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-023 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-023 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-023 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-024 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-024 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-024 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-024 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-024 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-024 | Fluoxetine | Fluoxetine | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 63739-493 | Fluoxetine | Fluoxetine Capsules | McKesson Packaging Services Business Unit of McKesson Corporation | ANDA | Current |
| 63739-494 | Fluoxetine | Fluoxetine Capsules | McKesson Packaging Services Business Unit of McKesson Corporation | ANDA | Current |
| 68001-129 | Fluoxetine | Fluoxetine | BluePoint Laboratories | ANDA | Current |
| 68001-129 | Fluoxetine | Fluoxetine | BluePoint Laboratories | ANDA | Current |
| 68071-3318 | Fluoxetine | Fluoxetine | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3367 | Fluoxetine | Fluoxetine | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 71335-0565 | Fluoxetine | Fluoxetine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0565 | Fluoxetine | Fluoxetine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0565 | Fluoxetine | Fluoxetine | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44416 | ORIG | 2009-04-14 |