Skip to content
Application 078578
- Type
- ANDA
- Sponsor
- RUBICON
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No |
| 002 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 003 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | TABLET;ORAL | 400MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 60505-2658 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | APOTEX Corp | ANDA | Current |
| 70518-3439 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3439 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-1985 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1985 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72888-039 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Advagen Pharma Limited | ANDA | Current |
| 72888-039 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Advagen Pharma Limited | ANDA | Current |
| 72888-060 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Advagen Pharma Limited | ANDA | Current |
| 72888-061 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Advagen Pharma Limited | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 44387 | ORIG | 2008-11-25 |