Application 022437
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRELSTAR | TRIPTORELIN PAMOATE | INJECTABLE;INTRAMUSCULAR | EQ 22.5MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-5906 | Trelstar | triptorelin pamoate | Allergan, Inc. | NDA | Current |
| 0023-5906 | Trelstar | triptorelin pamoate | Allergan, Inc. | NDA | Current |
| 74676-5906 | Trelstar | triptorelin pamoate | Verity Pharmaceuticals Inc. | NDA | Current |
| 74676-5906 | Trelstar | triptorelin pamoate | Verity Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83476 | SUPPL | 2025-09-25 |
| 83434 | SUPPL | 2025-09-25 |
| 81572 | SUPPL | 2025-03-14 |
| 81552 | SUPPL | 2025-03-13 |
| 78144 | SUPPL | 2024-04-15 |
| 78131 | SUPPL | 2024-04-15 |
| 76642 | SUPPL | 2023-11-21 |
| 76635 | SUPPL | 2023-11-20 |
| 73691 | SUPPL | 2023-03-06 |
| 73687 | SUPPL | 2023-03-06 |
| 56910 | SUPPL | 2018-12-21 |
| 56784 | SUPPL | 2018-12-18 |
| 17593 | SUPPL | 2014-07-15 |
| 7403 | SUPPL | 2014-07-15 |
| 29732 | SUPPL | 2013-03-15 |
| 17592 | SUPPL | 2013-03-15 |
| 44185 | ORIG | 2011-12-20 |
| 29731 | SUPPL | 2011-05-24 |
| 17591 | SUPPL | 2011-05-23 |
| 24310 | ORIG | 2011-02-17 |
| 38715 | SUPPL | 2011-01-20 |
| 29730 | SUPPL | 2011-01-20 |
| 42528 | ORIG | 2010-11-10 |
| 7402 | ORIG | 2010-03-18 |
| 38714 | ORIG | 2010-03-17 |