Application 009165
- Type
- NDA
- Sponsor
- ENDO PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DELATESTRYL | TESTOSTERONE ENANTHATE | INJECTABLE;INJECTION | 200MG/ML | No | No |
| 003 | DELATESTRYL | TESTOSTERONE ENANTHATE | INJECTABLE;INJECTION | 200MG/ML | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N009165-001 | DELATESTRYL | TESTOSTERONE ENANTHATE | 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | ||
| N009165-003 | DELATESTRYL | TESTOSTERONE ENANTHATE | 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N009165-001 | DELATESTRYL | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N009165-003 | DELATESTRYL | 200MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N009165-001 | DELATESTRYL | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N009165-003 | DELATESTRYL | 200MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N009165-001 | DELATESTRYL | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N009165-003 | DELATESTRYL | 200MG/ML | INJECTABLE / INJECTION | RLD, Approved before 1982 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N009165-001 | DELATESTRYL | 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N009165-003 | DELATESTRYL | 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | RLD, Approved before 1982 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| TESTOSTERONE ENANTHATE | TESTOSTERONE ENANTHATE | Eugia US LLC | 82a98132-9d5f-40a5-8c4f-f52f2a5de60e | 2026-06-12 | Warnings, Adverse reactions | TESTOSTERONE ENANTHATE |
| TESTOSTERONE ENANTHATE | TESTOSTERONE ENANTHATE | Hikma Pharmaceuticals USA Inc. | e89d6458-428c-4256-97a3-f1fa851293c1 | 2026-05-08 | Warnings, Adverse reactions | TESTOSTERONE ENANTHATE |
| XYOSTED | TESTOSTERONE ENANTHATE | Antares Pharma, Inc. | 8a3d204c-be26-49e0-8599-0ac12a272e81 | 2025-07-01 | Warnings, Adverse reactions | TESTOSTERONE ENANTHATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.