Application 076312
- Type
- ANDA
- Sponsor
- WATSON LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 15MG | No | No |
| 002 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 30MG | No | No |
| 003 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 45MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0591-1117 | Mirtazapine | Mirtazapine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-1117 | Mirtazapine | Mirtazapine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-1118 | Mirtazapine | Mirtazapine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-1118 | Mirtazapine | Mirtazapine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-1119 | Mirtazapine | Mirtazapine | Actavis Pharma, Inc. | ANDA | Current |
| 0591-1119 | Mirtazapine | Mirtazapine | Actavis Pharma, Inc. | ANDA | Current |
| 33261-074 | Mirtazapine | Mirtazapine | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42254-086 | Mirtazapine | Mirtazapine | Rebel Distributors Corp | ANDA | Current |
| 42254-087 | Mirtazapine | Mirtazapine | Rebel Distributors Corp | ANDA | Current |
| 42254-269 | Mirtazapine | Mirtazapine | Rebel Distributors Corp | ANDA | Current |
| 50436-3897 | Mirtazapine | Mirtazapine | Unit Dose Services | ANDA | Current |
| 64725-1117 | Mirtazapine | Mirtazapine | TYA Pharmaceuticals | ANDA | Current |
| 70518-0101 | Mirtazapine | Mirtazapine | REMEDYREPACK INC. | ANDA | Current |
| 71610-121 | Mirtazapine | Mirtazapine | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44303 | ORIG | 2005-08-01 |