Application 076219
- Type
- ANDA
- Sponsor
- UPSHER SMITH 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 |
|---|---|---|---|---|---|
| 0185-0020 | mirtazapine | mirtazapine | Eon Labs, Inc. | ANDA | Current |
| 0185-0212 | mirtazapine | mirtazapine | Eon Labs, Inc. | ANDA | Current |
| 0185-0222 | mirtazapine | mirtazapine | Eon Labs, Inc. | ANDA | Current |
| 43063-255 | mirtazapine | mirtazapine | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 67046-479 | mirtazapine | mirtazapine | Contract Pharmacy Services-PA | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44295 | ORIG | 2005-08-01 |