Application 075761
- Type
- ANDA
- Sponsor
- FRESENIUS KABI USA
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | INJECTABLE;INJECTION | 50MG/ML | No | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 51662-1363 | AMIODARONE HCI | AMIODARONE HCI | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1363 | AMIODARONE HCI | AMIODARONE HCI | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1363 | AMIODARONE HCI | AMIODARONE HCI | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 52584-616 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | General Injectables and Vaccines, Inc. | ANDA | Current |
| 63323-616 | Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-616 | Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 63323-616 | Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Fresenius Kabi USA, LLC | ANDA | Current |
| 70518-2792 | Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2792 | Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 70518-2792 | Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | REMEDYREPACK INC. | ANDA | Current |
| 71872-7034 | Amiodarone Hydrochloride | AMIODARONE HYDROCHLORIDE | Medical Purchasing Solutions, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 43024 | ORIG | 2006-04-20 |
| 23774 | ORIG | 2005-07-28 |
| 31010 | ORIG | 2003-04-15 |