Skip to contentApplication 208088
- Type
- NDA
- Sponsor
- LIPOCINE INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | TESTOSTERONE UNDECANOATE | TESTOSTERONE UNDECANOATE | UNKNOWN | UNKNOWN | Yes | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 54436-112 | Tlando | testosterone undecanoate | Antares Pharma, Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 82864 | SUPPL | 2025-07-15 |
| 82851 | SUPPL | 2025-07-14 |
| 82850 | SUPPL | 2025-07-14 |
| 73587 | ORIG | 2023-02-22 |
| 70638 | ORIG | 2022-03-29 |
| 70636 | ORIG | 2022-03-29 |
| 65541 | ORIG | 2020-12-09 |