Application 076307
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | MIRTAZAPINE | MIRTAZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | No | No |
| 002 | MIRTAZAPINE | MIRTAZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG | No | No |
| 003 | MIRTAZAPINE | MIRTAZAPINE | TABLET, ORALLY DISINTEGRATING;ORAL | 45MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0115-1653 | Mirtazapine | Mirtazapine | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1653 | Mirtazapine | Mirtazapine | Impax Generics | ANDA | Current |
| 0115-1654 | Mirtazapine | Mirtazapine | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1654 | Mirtazapine | Mirtazapine | Impax Generics | ANDA | Current |
| 0115-1656 | Mirtazapine | Mirtazapine | Amneal Pharmaceuticals of New York LLC | ANDA | Current |
| 0115-1656 | Mirtazapine | Mirtazapine | Impax Generics | ANDA | Current |
| 0591-2470 | Mirtazapine | Mirtazapine | Actavis Pharma, Inc. | ANDA | Current |
| 71335-0951 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
| 71335-0951 | Mirtazapine | Mirtazapine | Bryant Ranch Prepack | ANDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 23815 | ORIG | 2005-08-01 |