Application 208956
- Type
- NDA
- Sponsor
- ARBOR PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRIPTODUR KIT | TRIPTORELIN PAMOATE | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | EQ 22.5MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 24338-150 | TRIPTODUR | triptorelin | Arbor Pharmaceuticals, LLC | NDA | Current |
| 24338-150 | TRIPTODUR | triptorelin | Arbor Pharmaceuticals, LLC | NDA | Current |
| 24338-150 | TRIPTODUR | triptorelin | Azurity Pharmaceuticals, Inc. | NDA | Current |
| 24338-150 | TRIPTODUR | triptorelin | Arbor Pharmaceuticals, LLC | NDA | Current |
| 24338-150 | TRIPTODUR | triptorelin | Arbor Pharmaceuticals, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83460 | SUPPL | 2025-09-25 |
| 83459 | SUPPL | 2025-09-25 |
| 83427 | SUPPL | 2025-09-24 |
| 72833 | SUPPL | 2022-12-09 |
| 72832 | SUPPL | 2022-12-09 |
| 72822 | SUPPL | 2022-12-08 |
| 70829 | SUPPL | 2022-04-27 |
| 70828 | SUPPL | 2022-04-27 |
| 70811 | SUPPL | 2022-04-26 |
| 60466 | SUPPL | 2019-10-09 |
| 52677 | ORIG | 2018-02-21 |
| 48900 | ORIG | 2017-07-05 |
| 48872 | ORIG | 2017-06-30 |
| 48911 | ORIG | 2017-06-29 |