Application 207583
- Type
- ANDA
- Sponsor
- PADDOCK LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TESTOSTERONE UNDECANOATE | TESTOSTERONE UNDECANOATE | INJECTABLE;INTRAMUSCULAR | 750MG/3ML (250MG/ML) | No | No |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Tlando | TESTOSTERONE UNDECANOATE | Verity Pharmaceuticals Inc. | 4b0b92e9-6d3c-a0e5-e1c7-342999f72580 | 2026-02-25 | Warnings, Adverse reactions | TESTOSTERONE UNDECANOATE |
| Kyzatrex | TESTOSTERONE UNDECANOATE | Marius Pharmaceuticals | 7f7167a7-2a25-47e2-acf5-33f499fce971 | 2025-10-15 | Warnings, Adverse reactions | TESTOSTERONE UNDECANOATE |
| Jatenzo | TESTOSTERONE UNDECANOATE | TOLMAR Inc. | ed7b5d41-7475-4c10-99b9-b62b3434ae60 | 2025-09-30 | Warnings, Adverse reactions | TESTOSTERONE UNDECANOATE |
| Aveed | TESTOSTERONE UNDECANOATE | Endo USA, Inc. | f80f025b-17d8-40af-8739-20ce07902045 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | TESTOSTERONE UNDECANOATE |