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Application 078230
- Type
- ANDA
- Sponsor
- EPIC PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 0.25MG BASE | No | No |
| 002 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 0.5MG BASE | No | No |
| 003 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 1MG BASE | No | No |
| 004 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 2MG BASE | No | No |
| 005 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 3MG BASE | No | No |
| 006 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 4MG BASE | No | No |
| 007 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | TABLET;ORAL | EQ 5MG BASE | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 21695-792 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | Rebel Distributors Corp | ANDA | Current |
| 21695-794 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | Rebel Distributors Corp | ANDA | Current |
| 21695-798 | ROPINIROLE HYDROCHLORIDE | ROPINIROLE HYDROCHLORIDE | Rebel Distributors Corp | ANDA | Current |