Application 065058
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFACLOR | CEFACLOR | TABLET, EXTENDED RELEASE;ORAL | EQ 375MG BASE | No | No |
| 002 | CEFACLOR | CEFACLOR | TABLET, EXTENDED RELEASE;ORAL | EQ 500MG BASE | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065058-001 | CEFACLOR | CEFACLOR | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2002-09-04 | ||
| A065058-002 | CEFACLOR | CEFACLOR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | RS | 2002-09-04 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-01-26 05:58 UTC | 2023-01 | A065058-001 | CEFACLOR | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2002-09-04 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A065058-002 | CEFACLOR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | RS | 2002-09-04 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065058-001 | CEFACLOR | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2002-09-04 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065058-002 | CEFACLOR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | RS | 2002-09-04 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A065058-001 | CEFACLOR | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2002-09-04 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A065058-002 | CEFACLOR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | RS | 2002-09-04 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A065058-001 | CEFACLOR | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2002-09-04 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A065058-002 | CEFACLOR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | RS | 2002-09-04 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065058-001 | CEFACLOR | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2002-09-04 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A065058-002 | CEFACLOR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | RS | 2002-09-04 | cb3db0bc1861… | |
| 2026-08-01 22:54:32 | 2026-06 | A065058-001 | CEFACLOR | EQ 375MG BASE | TABLET, EXTENDED RELEASE / ORAL | 2002-09-04 | a50c72e98297… | ||
| 2026-08-01 22:54:32 | 2026-06 | A065058-002 | CEFACLOR | EQ 500MG BASE | TABLET, EXTENDED RELEASE / ORAL | RS | 2002-09-04 | 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 |
|---|---|---|---|---|---|---|
| Cefaclor | CEFACLOR | Teva Pharmaceuticals USA, Inc. | 0878bdc2-0410-4938-9890-96523aa81c2f | 2019-07-31 | Warnings, Adverse reactions | 065058 ANDA065058 0093-1087 |