Application 078626
- Type
- ANDA
- Sponsor
- MYLAN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 25MG BASE | No | No |
| 002 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 50MG BASE | No | No |
| 003 | SERTRALINE HYDROCHLORIDE | SERTRALINE HYDROCHLORIDE | TABLET;ORAL | EQ 100MG BASE | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-8011 | Sertraline Hydrochloride | sertraline | Mylan Pharmaceuticals Inc | ANDA | Current |
| 0378-8121 | Sertraline Hydrochloride | sertraline | Mylan Pharmaceuticals Inc | ANDA | Current |
| 43353-787 | Sertraline Hydrochloride | sertraline | Aphena Pharma Solutions - Tennessee, Inc. | ANDA | Current |
| 53808-0954 | Sertraline Hydrochloride | sertraline | State of Florida DOH Central Pharmacy | ANDA | Current |
| 53808-1060 | Sertraline Hydrochloride | sertraline | State of Florida DOH Central Pharmacy | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 44390 | ORIG | 2008-02-28 |