Application 021732
- Type
- NDA
- Sponsor
- ENDO PHARM
Related Records
Application Products
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VANTAS | HISTRELIN ACETATE | IMPLANT;SUBCUTANEOUS | 50MG | Yes | Yes |
NDC Listings For This Application
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 67979-500 | Vantas | histrelin acetate | Endo Pharmaceuticals Inc. | NDA | Current |
| 67979-500 | Vantas | histrelin acetate | Endo Pharmaceuticals Solutions Inc. | NDA | Current |
| 67979-500 | Vantas | histrelin acetate | Endo Pharmaceuticals Inc. | NDA | Current |
| 67979-500 | Vantas | histrelin acetate | Endo Pharmaceuticals Inc. | NDA | Current |
| 67979-500 | Vantas | histrelin acetate | Endo Pharmaceuticals Inc. | NDA | Current |
| 67979-500 | Vantas | histrelin acetate | Endo Pharmaceuticals Inc. | NDA | Current |
Documents
| Document | Submission type | Date |
|---|---|---|
| 85891 | SUPPL | 2026-05-12 |
| 85847 | SUPPL | 2026-05-08 |
| 83479 | SUPPL | 2025-09-25 |
| 83441 | SUPPL | 2025-09-25 |
| 72010 | SUPPL | 2022-09-02 |
| 71876 | SUPPL | 2022-08-24 |
| 65685 | SUPPL | 2020-12-22 |
| 65640 | SUPPL | 2020-12-21 |
| 57612 | SUPPL | 2019-02-14 |
| 57503 | SUPPL | 2019-02-12 |
| 6085 | SUPPL | 2014-07-10 |
| 16279 | SUPPL | 2014-01-10 |
| 37556 | SUPPL | 2013-04-09 |
| 6084 | SUPPL | 2013-04-09 |
| 6083 | SUPPL | 2011-02-10 |
| 6082 | SUPPL | 2011-02-10 |
| 6081 | SUPPL | 2011-02-10 |
| 37555 | SUPPL | 2011-02-09 |
| 37554 | SUPPL | 2011-02-09 |
| 37553 | SUPPL | 2011-02-09 |
| 28491 | SUPPL | 2011-01-20 |
| 16278 | SUPPL | 2011-01-20 |
| 21797 | ORIG | 2006-07-05 |
| 16277 | ORIG | 2004-10-15 |
| 6080 | ORIG | 2004-10-15 |