Application 091030
- Type
- ANDA
- Sponsor
- WEST-WARD PHARM CORP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFOTETAN | CEFOTETAN DISODIUM | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091030-001 | CEFOTETAN | CEFOTETAN DISODIUM | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 2011-10-26 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A091030-001 | CEFOTETAN | EQ 10GM BASE/VIAL | INJECTABLE / INJECTION | 2011-10-26 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cefotetan | CEFOTETAN DISODIUM | Fresenius Kabi USA, LLC | bd22c66b-8a1c-44c8-b5b6-3ab0ce5c800e | 2025-01-08 | Warnings, Adverse reactions | Cefotetan CEFOTETAN DISODIUM |
| Cefotetan | CEFOTETAN | Hikma Pharmaceuticals USA Inc. | 33b13b93-58ce-44c7-b9a2-af3b3a333f80 | 2024-04-11 | Warnings, Adverse reactions | Cefotetan |