Application 076217
- Type
- ANDA
- Sponsor
- MYLAN INSTITUTIONAL
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 |
|---|
| 0404-9815 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Henry Schein, Inc | ANDA | Current |
| 0404-9815 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Henry Schein, Inc | ANDA | Current |
| 0404-9815 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Henry Schein, Inc | ANDA | Current |
| 0404-9815 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Henry Schein, Inc | ANDA | Current |
| 51662-1358 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1358 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 51662-1358 | AMIODARONE HYDROCHLORIDE | AMIODARONE HYDROCHLORIDE | HF Acquisition Co LLC, DBA HealthFirst | ANDA | Current |
| 52584-153 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-153 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-153 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-153 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 52584-153 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | General Injectables & Vaccines, Inc | ANDA | Current |
| 67457-153 | Amiodarone Hydrochloride | amiodarone hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-153 | Amiodarone Hydrochloride | amiodarone hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 67457-153 | Amiodarone Hydrochloride | amiodarone hydrochloride | Mylan Institutional LLC | ANDA | Current |
| 71872-7163 | Amiodarone Hydrochloride | amiodarone hydrochloride | Medical Purchasing Solutions, LLC | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23808 | ORIG | 2005-07-28 |