Application 065092
- Type
- ANDA
- Sponsor
- RANBAXY LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RANICLOR | CEFACLOR | TABLET, CHEWABLE;ORAL | EQ 125MG BASE | No | No |
| 002 | RANICLOR | CEFACLOR | TABLET, CHEWABLE;ORAL | EQ 187MG BASE | No | No |
| 003 | RANICLOR | CEFACLOR | TABLET, CHEWABLE;ORAL | EQ 250MG BASE | No | No |
| 004 | RANICLOR | CEFACLOR | TABLET, CHEWABLE;ORAL | EQ 375MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065092-001 | RANICLOR | CEFACLOR | EQ 125MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | ||
| A065092-002 | RANICLOR | CEFACLOR | EQ 187MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | ||
| A065092-003 | RANICLOR | CEFACLOR | EQ 250MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | ||
| A065092-004 | RANICLOR | CEFACLOR | EQ 375MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A065092-001 | RANICLOR | EQ 125MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065092-002 | RANICLOR | EQ 187MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065092-003 | RANICLOR | EQ 250MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065092-004 | RANICLOR | EQ 375MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065092-001 | RANICLOR | EQ 125MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065092-002 | RANICLOR | EQ 187MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065092-003 | RANICLOR | EQ 250MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065092-004 | RANICLOR | EQ 375MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065092-001 | RANICLOR | EQ 125MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065092-002 | RANICLOR | EQ 187MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065092-003 | RANICLOR | EQ 250MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065092-004 | RANICLOR | EQ 375MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065092-001 | RANICLOR | EQ 125MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065092-002 | RANICLOR | EQ 187MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065092-003 | RANICLOR | EQ 250MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065092-004 | RANICLOR | EQ 375MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065092-001 | RANICLOR | EQ 125MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065092-002 | RANICLOR | EQ 187MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065092-003 | RANICLOR | EQ 250MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065092-004 | RANICLOR | EQ 375MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065092-001 | RANICLOR | EQ 125MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065092-002 | RANICLOR | EQ 187MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065092-003 | RANICLOR | EQ 250MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065092-004 | RANICLOR | EQ 375MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065092-001 | RANICLOR | EQ 125MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065092-002 | RANICLOR | EQ 187MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065092-003 | RANICLOR | EQ 250MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065092-004 | RANICLOR | EQ 375MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065092-001 | RANICLOR | EQ 125MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065092-002 | RANICLOR | EQ 187MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065092-003 | RANICLOR | EQ 250MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065092-004 | RANICLOR | EQ 375MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065092-001 | RANICLOR | EQ 125MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065092-002 | RANICLOR | EQ 187MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065092-003 | RANICLOR | EQ 250MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065092-004 | RANICLOR | EQ 375MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065092-001 | RANICLOR | EQ 125MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065092-002 | RANICLOR | EQ 187MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065092-003 | RANICLOR | EQ 250MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065092-004 | RANICLOR | EQ 375MG BASE | TABLET, CHEWABLE / ORAL | 2003-12-22 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| Cefaclor | CEFACLOR | Carlsbad Technology, Inc. | 2f61354e-bcb0-41aa-955f-51eabc11387b | 2025-05-01 | Warnings, Adverse reactions | CEFACLOR |
| Cefaclor | CEFACLOR | A-S Medication Solutions | d79a4b28-ef2b-4f0f-baec-002df7d06dd4 | 2024-01-31 | Warnings, Adverse reactions | CEFACLOR |
| Cefaclor | CEFACLOR | Azorian Pharma, LLC | 224af904-38f3-4210-a750-e21006db4c66 | 2022-11-01 | Warnings, Adverse reactions | CEFACLOR |
| Cefaclor | CEFACLOR | Teva Pharmaceuticals USA, Inc. | 0878bdc2-0410-4938-9890-96523aa81c2f | 2019-07-31 | Warnings, Adverse reactions | CEFACLOR |