Application 071563
- Type
- ANDA
- Sponsor
- QUAD PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DACARBAZINE | DACARBAZINE | Injectable; Injection | 500MG/VIAL | 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 |
|---|---|---|---|---|---|---|
| Dacarbazine | DACARBAZINE | Hikma Pharmaceuticals USA Inc. | 0d81315c-7021-4091-b703-ad135390c936 | 2025-09-22 | Boxed warning, Warnings, Adverse reactions | Dacarbazine DACARBAZINE |
| Dacarbazine | DACARBAZINE | Meitheal Pharmaceuticals Inc. | 64037f45-6245-49f0-9ae8-18d75753ae1f | 2024-03-22 | Boxed warning, Warnings, Adverse reactions | Dacarbazine DACARBAZINE |
| Dacarbazine | DACARBAZINE | Fresenius Kabi USA, LLC | b6b97e41-5f15-498c-abfb-d8443ea4d216 | 2022-10-20 | Boxed warning, Warnings, Adverse reactions | Dacarbazine DACARBAZINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.