approval · primary record
LEUPROLIDE ACETATE
6 approval events · latest 2026-05-06
| Agency | FDA |
|---|---|
| Submission type | NDA |
| Latest action | 2026-05-06 |
| Approval events | 6 |
| Brand | ELIGARD KIT |
| Sponsor | TOLMAR |
| Route | SUBCUTANEOUS |
Approval history
6 actions on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2026-05-06 | FDA | NDA | ELIGARD KIT | TOLMAR | SUBCUTANEOUS |
| 2025-11-14 | FDA | NDA | LUPRON DEPOT-PED KIT | ABBVIE ENDOCRINE INC | INTRAMUSCULAR |
| 2025-09-23 | FDA | NDA | FENSOLVI KIT | TOLMAR | SUBCUTANEOUS |
| 2025-09-10 | FDA | NDA | LUPRON DEPOT | ABBVIE ENDOCRINE INC | INJECTION |
| 2025-08-18 | FDA | NDA | LUPRON DEPOT | ABBVIE ENDOCRINE INC | INJECTION |
| 2024-11-14 | FDA | NDA | LEUPROLIDE ACETATE FOR DEPOT SUSPENSION | INVAGEN PHARMS | INTRAMUSCULAR |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:30:21.553Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:leuprolide-acetate
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Leuprolide Acetate · compound