Application 204742
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
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 |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0615-8258 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-8258 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 50090-3015 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3015 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3015 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 55154-8185 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-8185 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-8185 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Cardinal Health | ANDA | Current |
| 55154-8185 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Cardinal Health | ANDA | Current |
| 60687-437 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-437 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-437 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | American Health Packaging | ANDA | Current |
| 60687-437 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | American Health Packaging | ANDA | Current |
| 65862-732 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-732 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-732 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-732 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 70518-1939 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1939 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1939 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1939 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1939 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70934-280 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-280 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-280 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-280 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-1297 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1297 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |