Application 020715
- Type
- NDA
- Sponsor
- ALLERGAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRELSTAR | TRIPTORELIN PAMOATE | INJECTABLE;INTRAMUSCULAR | EQ 3.75MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0023-5902 | Trelstar | triptorelin pamoate | Allergan, Inc. | NDA | Current |
| 0023-5902 | Trelstar | triptorelin pamoate | Allergan, Inc. | NDA | Current |
| 74676-5902 | Trelstar | triptorelin pamoate | Verity Pharmaceuticals Inc. | NDA | Current |
| 74676-5902 | Trelstar | triptorelin pamoate | Verity Pharmaceuticals Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83477 | SUPPL | 2025-09-25 |
| 83432 | SUPPL | 2025-09-25 |
| 81570 | SUPPL | 2025-03-14 |
| 81550 | SUPPL | 2025-03-13 |
| 78142 | SUPPL | 2024-04-15 |
| 78129 | SUPPL | 2024-04-15 |
| 76639 | SUPPL | 2023-11-21 |
| 76633 | SUPPL | 2023-11-20 |
| 73689 | SUPPL | 2023-03-06 |
| 73685 | SUPPL | 2023-03-06 |
| 56908 | SUPPL | 2018-12-21 |
| 56782 | SUPPL | 2018-12-18 |
| 25621 | SUPPL | 2014-07-15 |
| 13279 | SUPPL | 2014-07-15 |
| 25620 | SUPPL | 2013-03-15 |
| 13278 | SUPPL | 2013-03-15 |
| 23595 | ORIG | 2011-12-20 |
| 25619 | SUPPL | 2011-05-24 |
| 35210 | SUPPL | 2011-05-23 |
| 35209 | SUPPL | 2011-01-20 |
| 3184 | SUPPL | 2011-01-20 |
| 3183 | SUPPL | 2008-04-16 |
| 25618 | SUPPL | 2005-10-25 |
| 20873 | ORIG | 2002-07-31 |
| 25617 | SUPPL | 2002-01-15 |
| 3182 | SUPPL | 2002-01-15 |
| 35208 | ORIG | 2000-06-15 |
| 25616 | ORIG | 2000-06-15 |