Application 065412
- Type
- ANDA
- Sponsor
- YUNG SHIN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFACLOR | CEFACLOR | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML | No | No |
| 002 | CEFACLOR | CEFACLOR | FOR SUSPENSION;ORAL | EQ 187MG BASE/5ML | No | No |
| 003 | CEFACLOR | CEFACLOR | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML | No | No |
| 004 | CEFACLOR | CEFACLOR | FOR SUSPENSION;ORAL | EQ 375MG BASE/5ML | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065412-001 | CEFACLOR | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | ||
| A065412-002 | CEFACLOR | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | ||
| A065412-003 | CEFACLOR | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | ||
| A065412-004 | CEFACLOR | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2012-02-17 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A065412-001 | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065412-002 | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065412-003 | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065412-004 | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2012-02-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065412-001 | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065412-002 | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065412-003 | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065412-004 | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2012-02-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065412-001 | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065412-002 | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065412-003 | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065412-004 | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2012-02-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065412-001 | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065412-002 | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065412-003 | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065412-004 | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2012-02-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065412-001 | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065412-002 | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065412-003 | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065412-004 | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2012-02-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065412-001 | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065412-002 | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065412-003 | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065412-004 | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2012-02-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065412-001 | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065412-002 | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065412-003 | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065412-004 | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2012-02-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065412-001 | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065412-002 | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065412-003 | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065412-004 | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2012-02-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065412-001 | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065412-002 | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065412-003 | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065412-004 | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2012-02-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065412-001 | CEFACLOR | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065412-002 | CEFACLOR | EQ 187MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065412-003 | CEFACLOR | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2012-02-17 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065412-004 | CEFACLOR | EQ 375MG BASE/5ML | FOR SUSPENSION / ORAL | RS | 2012-02-17 | d8e5a09893c0… |
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 | Azorian Pharma, LLC | 224af904-38f3-4210-a750-e21006db4c66 | 2022-11-01 | Warnings, Adverse reactions | 065412 ANDA065412 81948-6250 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16571-070 | Cefaclor | Cefaclor | Pack Pharmaceuticals, LLC | ANDA | Current |
| 16571-071 | Cefaclor | Cefaclor | Pack Pharmaceuticals, LLC | ANDA | Current |
| 16571-072 | Cefaclor | Cefaclor | Pack Pharmaceuticals, LLC | ANDA | Current |
| 23594-125 | Cefaclor | cefaclor | Cerecor, Inc. | ANDA | Current |
| 23594-125 | Cefaclor | cefaclor | Aytu Therapeutics, LLC | ANDA | Current |
| 23594-125 | Cefaclor | cefaclor | Aytu Therapeutics, LLC | ANDA | Current |
| 23594-125 | Cefaclor | cefaclor | Aytu Therapeutics, LLC | ANDA | Current |
| 23594-125 | Cefaclor | cefaclor | Aytu Therapeutics, LLC | ANDA | Current |
| 23594-125 | Cefaclor | cefaclor | Zylera Pharmaceuticals, L | ANDA | Current |
| 23594-250 | Cefaclor | cefaclor | Cerecor, Inc. | ANDA | Current |
| 23594-250 | Cefaclor | cefaclor | Aytu Therapeutics, LLC | ANDA | Current |
| 23594-250 | Cefaclor | cefaclor | Aytu Therapeutics, LLC | ANDA | Current |
| 23594-250 | Cefaclor | cefaclor | Aytu Therapeutics, LLC | ANDA | Current |
| 23594-250 | Cefaclor | cefaclor | Aytu Therapeutics, LLC | ANDA | Current |
| 23594-250 | Cefaclor | cefaclor | Zylera Pharmaceuticals, L | ANDA | Current |
| 23594-375 | Cefaclor | cefaclor | Cerecor, Inc. | ANDA | Current |
| 23594-375 | Cefaclor | cefaclor | Aytu Therapeutics, LLC | ANDA | Current |
| 23594-375 | Cefaclor | cefaclor | Aytu Therapeutics, LLC | ANDA | Current |
| 23594-375 | Cefaclor | cefaclor | Aytu Therapeutics, LLC | ANDA | Current |
| 23594-375 | Cefaclor | cefaclor | Aytu Therapeutics, LLC | ANDA | Current |
| 23594-375 | Cefaclor | cefaclor | Zylera Pharmaceuticals, L | ANDA | Current |
| 61442-173 | Cefaclor | Cefaclor | Carlsbad Technology, Inc. | ANDA | Current |
| 61442-174 | Cefaclor | Cefaclor | Carlsbad Technology, Inc. | ANDA | Current |
| 61442-175 | Cefaclor | Cefaclor | Carlsbad Technology, Inc. | ANDA | Current |
| 61442-176 | Cefaclor | Cefaclor | Carlsbad Technology, Inc. | ANDA | Current |
| 81948-6250 | Cefaclor | cefaclor | Azorian Pharma, LLC | ANDA | Current |