Application 204744
- Type
- ANDA
- Sponsor
- LANNETT CO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 12.5MG BASE | No | No |
| 002 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 25MG BASE | No | No |
| 003 | PAROXETINE HYDROCHLORIDE | PAROXETINE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 37.5MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 62135-425 | Paroxetine | Paroxetine | Chartwell RX, LLC | ANDA | Current |
| 62135-426 | Paroxetine | Paroxetine | Chartwell RX, LLC | ANDA | Current |
| 62135-427 | Paroxetine | Paroxetine | Chartwell RX, LLC | ANDA | Current |
| 62175-470 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-470 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-470 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Kremers Urban Pharmaceuticals Inc. | ANDA | Current |
| 62175-470 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-470 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-470 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-471 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-471 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-471 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-471 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-471 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Kremers Urban Pharmaceuticals Inc. | ANDA | Current |
| 62175-471 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-472 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-472 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-472 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-472 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 62175-472 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Kremers Urban Pharmaceuticals Inc. | ANDA | Current |
| 62175-472 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 63629-8527 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8527 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8527 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 70518-2118 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2118 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2118 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2118 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2118 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-1205 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1205 | Paroxetine Hydrochloride | Paroxetine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |