Application 079029
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA INC
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 |
|---|
| 0615-8213 | Amiodarone hydrochloride | Amiodarone hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8213 | Amiodarone hydrochloride | Amiodarone hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0904-6556 | Amiodarone hydrochloride | Amiodarone hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6556 | Amiodarone hydrochloride | Amiodarone hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 21695-796 | Amiodarone hydrochloride | Amiodarone hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 50090-2308 | Amiodarone hydrochloride | Amiodarone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 53808-1066 | Amiodarone hydrochloride | Amiodarone hydrochloride | State of Florida DOH Central Pharmacy | ANDA | Current |
| 55154-4996 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | Cardinal Health | ANDA | Current |
| 55154-4996 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | Cardinal Health | ANDA | Current |
| 55154-4996 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | Cardinal Health | ANDA | Current |
| 55154-7890 | Amiodarone hydrochloride | Amiodarone hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7890 | Amiodarone hydrochloride | Amiodarone hydrochloride | Cardinal Health | ANDA | Current |
| 63629-7300 | Amiodarone hydrochloride | Amiodarone hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7300 | Amiodarone hydrochloride | Amiodarone hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7300 | Amiodarone hydrochloride | Amiodarone hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63739-051 | Amiodarone hydrochloride | Amiodarone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-051 | Amiodarone hydrochloride | Amiodarone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-051 | Amiodarone hydrochloride | Amiodarone hydrochloride | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 65084-477 | Amiodarone hydrochloride | Amiodarone hydrochloride | McKesson Corporation dba RX Pak | ANDA | Current |
| 65084-477 | Amiodarone hydrochloride | Amiodarone hydrochloride | McKesson Corporation dba RX Pak | ANDA | Current |
| 65841-631 | Amiodarone hydrochloride | Amiodarone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-631 | Amiodarone hydrochloride | Amiodarone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-631 | Amiodarone hydrochloride | Amiodarone hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 65841-631 | Amiodarone hydrochloride | Amiodarone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 68084-371 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-371 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68084-371 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | American Health Packaging | ANDA | Current |
| 68382-227 | Amiodarone hydrochloride | Amiodarone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-227 | Amiodarone hydrochloride | Amiodarone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-227 | Amiodarone hydrochloride | Amiodarone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 70518-1571 | Amiodarone hydrochloride | Amiodarone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1571 | Amiodarone hydrochloride | Amiodarone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23927 | ORIG | 2008-11-13 |