Application 209863
- Type
- NDA
- Sponsor
- ANTARES PHARMA INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | SOLUTION;SUBCUTANEOUS | 50MG/0.5ML (50MG/0.5ML) | Yes | Yes |
| 002 | XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | SOLUTION;SUBCUTANEOUS | 75MG/0.5ML (75MG/0.5ML) | Yes | Yes |
| 003 | XYOSTED (AUTOINJECTOR) | TESTOSTERONE ENANTHATE | SOLUTION;SUBCUTANEOUS | 100MG/0.5ML (100MG/0.5ML) | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54436-200 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-200 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-200 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-200 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-200 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-200 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-250 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-250 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-250 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-250 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-250 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-250 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-275 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-275 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-275 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-275 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-275 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
| 54436-275 | XYOSTED | testosterone enanthate | Antares Pharma, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82865 | SUPPL | 2025-07-15 |
| 82855 | SUPPL | 2025-07-14 |
| 82854 | SUPPL | 2025-07-11 |
| 60997 | SUPPL | 2019-11-20 |
| 60974 | SUPPL | 2019-11-20 |
| 58098 | ORIG | 2019-03-27 |
| 55880 | ORIG | 2018-10-11 |
| 55795 | ORIG | 2018-10-03 |
| 55794 | ORIG | 2018-10-03 |