Application 063029
- Type
- ANDA
- Sponsor
- ACP NIMBLE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 150MG BASE | No | No |
| 002 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | CAPSULE;ORAL | EQ 300MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A063029-001 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | ||
| A063029-002 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 |
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 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | 1989-09-20 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | 2005-08-05 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 1989-09-20 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2005-08-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 1989-09-20 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2005-08-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 1989-09-20 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2005-08-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 1989-09-20 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2005-08-05 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 1989-09-20 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2005-08-05 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A063029-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 1989-09-20 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A063029-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2005-08-05 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063029-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063029-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A063029-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A063029-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A063029-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A063029-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A063029-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A063029-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A063029-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A063029-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A063029-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A063029-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A063029-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A063029-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A063029-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A063029-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A063029-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A063029-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A063029-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A063029-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A063029-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A063029-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A063029-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A063029-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A063029-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A063029-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A063029-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A063029-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A063029-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A063029-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A063029-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A063029-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A063029-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A063029-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A063029-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A063029-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A063029-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A063029-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A063029-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A063029-002 | AB | 1 | 3f0d92c62455… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0713-3171 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-3171 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-3171 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | G&W Laboratories, Inc. | ANDA | Current |
| 0713-3171 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-5256 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-5256 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 0713-5256 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | G&W Laboratories, Inc. | ANDA | Current |
| 0713-5256 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Cosette Pharmaceuticals, Inc. | ANDA | Current |
| 50090-3242 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3242 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 55154-5546 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Cardinal Health | ANDA | Current |
| 63187-381 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-381 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Proficient Rx LP | ANDA | Current |
| 67296-1315 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1315 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1315 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68788-6401 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6401 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0238 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0429 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0454 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0454 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Bryant Ranch Prepack | ANDA | Current |