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Application 075389
- Type
- ANDA
- Sponsor
- MAYNE PHARMA 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 |
|---|
| 16714-843 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-843 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-843 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-843 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-843 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-844 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-844 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-844 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-844 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-844 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-845 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-845 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-845 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-845 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-845 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 50090-5062 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5062 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50268-097 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | AvPAK | ANDA | Current |
| 50268-097 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | AvPAK | ANDA | Current |
| 51862-240 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-240 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-240 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-241 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-241 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-241 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-242 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-242 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
| 51862-242 | Amiodarone Hydrochloride | Amiodarone Hydrochloride | Mayne Pharma Inc. | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23762 | ORIG | 2005-07-28 |
| 8643 | ORIG | 2001-01-25 |