Application 202786
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 2MG BASE | No | No |
| 002 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 4MG BASE | No | No |
| 003 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 6MG BASE | No | No |
| 004 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 8MG BASE | No | No |
| 005 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | EQ 12MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 13811-639 | Ropinirole | Ropinirole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-639 | Ropinirole | Ropinirole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-640 | Ropinirole | Ropinirole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-640 | Ropinirole | Ropinirole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-641 | Ropinirole | Ropinirole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-641 | Ropinirole | Ropinirole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-642 | Ropinirole | Ropinirole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-642 | Ropinirole | Ropinirole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-643 | Ropinirole | Ropinirole | Trigen Laboratories, LLC | ANDA | Current |
| 13811-643 | Ropinirole | Ropinirole | Trigen Laboratories, LLC | ANDA | Current |
| 46708-262 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-262 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-263 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-263 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-264 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-264 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-265 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-265 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-266 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 46708-266 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Limited | ANDA | Current |
| 62332-107 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-107 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-108 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-108 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-109 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-109 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-110 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-110 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-111 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Inc. | ANDA | Current |
| 62332-111 | Ropinirole | Ropinirole | Alembic Pharmaceuticals Inc. | ANDA | Current |