Application 201576
- Type
- ANDA
- Sponsor
- DR REDDYS LABS 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 |
|---|
| 55111-659 | Ropinirole | Ropinirole | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-659 | Ropinirole | Ropinirole | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-661 | Ropinirole | Ropinirole | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-661 | Ropinirole | Ropinirole | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-662 | Ropinirole | Ropinirole | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-662 | Ropinirole | Ropinirole | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-727 | Ropinirole | Ropinirole | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-727 | Ropinirole | Ropinirole | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-728 | Ropinirole | Ropinirole | Dr. Reddys Laboratories Limited | ANDA | Current |
| 55111-728 | Ropinirole | Ropinirole | Dr. Reddys Laboratories Limited | ANDA | Current |