Application 213446
- Type
- ANDA
- Sponsor
- UNICHEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 29300-359 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 50090-5766 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 70518-3246 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-1942 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1942 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |