Application 216318
- Type
- NDA
- Sponsor
- SLAYBACK PHARMA LLC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TESTOSTERONE CYPIONATE | TESTOSTERONE CYPIONATE | INJECTABLE;INJECTION | 200MG/ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 71225-127 | TESTOSTERONE | TESTOSTERONE CYPIONATE | Slayback Pharma LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82875 | SUPPL | 2025-07-15 |
| 82840 | SUPPL | 2025-07-14 |
| 82839 | SUPPL | 2025-07-14 |
| 81684 | SUPPL | 2025-03-24 |
| 80645 | SUPPL | 2024-12-19 |
| 77386 | SUPPL | 2024-03-04 |
| 77384 | SUPPL | 2024-02-02 |
| 73619 | ORIG | 2023-02-28 |
| 71211 | ORIG | 2022-06-03 |
| 71210 | ORIG | 2022-06-03 |
| 71209 | ORIG | 2022-06-03 |