Application 021288
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRELSTAR | TRIPTORELIN PAMOATE | INJECTABLE;INTRAMUSCULAR | EQ 11.25MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-5904 | Trelstar | triptorelin pamoate | Allergan, Inc. | NDA | Current |
| 0023-5904 | Trelstar | triptorelin pamoate | Allergan, Inc. | NDA | Current |
| 74676-5904 | Trelstar | triptorelin pamoate | Verity Pharmaceuticals Inc. | NDA | Current |
| 74676-5904 | Trelstar | triptorelin pamoate | Verity Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83478 | SUPPL | 2025-09-25 |
| 83433 | SUPPL | 2025-09-25 |
| 81571 | SUPPL | 2025-03-14 |
| 81551 | SUPPL | 2025-03-13 |
| 78143 | SUPPL | 2024-04-15 |
| 78130 | SUPPL | 2024-04-15 |
| 76641 | SUPPL | 2023-11-21 |
| 76634 | SUPPL | 2023-11-20 |
| 73690 | SUPPL | 2023-03-06 |
| 73686 | SUPPL | 2023-03-06 |
| 56909 | SUPPL | 2018-12-21 |
| 56783 | SUPPL | 2018-12-18 |
| 27395 | SUPPL | 2014-07-15 |
| 14902 | SUPPL | 2014-07-15 |
| 36593 | SUPPL | 2013-03-15 |
| 4934 | SUPPL | 2013-03-15 |
| 44114 | ORIG | 2011-12-20 |
| 27394 | SUPPL | 2011-05-24 |
| 36592 | SUPPL | 2011-05-23 |
| 14901 | SUPPL | 2011-01-20 |
| 4933 | SUPPL | 2011-01-20 |
| 4932 | SUPPL | 2008-04-16 |
| 27393 | SUPPL | 2005-10-25 |
| 21577 | ORIG | 2002-01-07 |
| 36591 | ORIG | 2001-06-29 |
| 4931 | ORIG | 2001-06-29 |