Application 065061
- Type
- ANDA
- Sponsor
- SUN PHARM INDS LTD
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 |
|---|---|---|---|---|---|---|---|
| A065061-001 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | |
| A065061-002 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065061-001 | AB |
| A065061-002 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065061-001 | CLINDAMYCIN HYDROCHLORIDE | EQ 150MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065061-002 | CLINDAMYCIN HYDROCHLORIDE | EQ 300MG BASE | CAPSULE / ORAL | AB | 2001-02-02 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A065061-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065061-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065061-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065061-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065061-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065061-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A065061-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A065061-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A065061-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A065061-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A065061-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A065061-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A065061-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A065061-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A065061-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A065061-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065061-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A065061-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065061-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065061-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A065061-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A065061-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A065061-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A065061-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065061-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065061-002 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065061-001 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065061-002 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065061-001 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065061-002 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065061-001 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065061-002 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A065061-001 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A065061-002 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A065061-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A065061-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065061-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065061-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A065061-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A065061-002 | AB | 1 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Cardinal Health 107, LLC | b22be885-f441-473e-879a-862588dcf89d | 2026-08-13 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 55154-7276 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | REMEDYREPACK INC. | 7f7fc73a-86e1-4d3e-8c83-1c74621e4af4 | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | HAWAII REPACK, INC. | c6703df0-b41d-439f-8e0d-d30b3039b3f8 | 2026-07-18 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | fadc321a-2291-4268-936f-0743fdddbe7f | 2026-07-08 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Major Pharmaceuticals | f9e6ed50-ad03-4a9e-8760-8733e04a058c | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 0904-5959 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 1dbd8448-c1e5-46df-8060-50ef82380445 | 2026-06-19 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 63304-693 63304-692 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Unit Dose Solutions, Inc. | 535e7e17-d020-4aa6-e063-6294a90ae114 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | a69260bb-31b5-4f77-e053-2995a90a37e1 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 51407-373 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Northwind Health Company, LLC | f781897a-ab54-7373-e053-6294a90a89a3 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 51655-964 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 4730ab20-09e2-d32a-e063-6394a90ae125 | 2025-12-30 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
| Clindamycin Hydrochloride | CLINDAMYCIN HYDROCHLORIDE | American Health Packaging | 3f6b2c5a-e581-414f-bc9e-eaf66a5685cd | 2025-06-18 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
| Clindamycin HCL | CLINDAMYCIN HCL | Advanced Rx of Tennessee, LLC | b43dc396-17ef-a523-e053-2a95a90ac872 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 2b13d66d-4f48-477e-ba32-20e85d0e708d | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Bryant Ranch Prepack | 7537fbab-c792-4b77-8736-c24b69cf48ea | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 678912ff-a0c1-171b-e053-2991aa0ad128 | 2024-06-07 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 63f26644-b7ab-98c1-e053-2a91aa0af5d3 | 2024-06-06 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 337870c6-11e0-4d1a-a26e-afe042ee08c3 | 2024-01-07 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 600c5ac7-64f7-44ac-9e83-cc1036471eec | 2023-12-10 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 50090-1985 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | A-S Medication Solutions | 22bf9385-cad3-43a7-802f-131b6826b5a5 | 2023-09-10 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 50090-0967 |
| Clindamycin hydrochloride | CLINDAMYCIN HYDROCHLORIDE | Asclemed USA, Inc. | cd5a1db8-9ddf-4de3-b856-bc3e8fb29061 | 2023-05-02 | Boxed warning, Warnings, Adverse reactions | 065061 ANDA065061 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0440-7300 | Clindamycin hydrochloride | Clindamycin hydrochloride | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-7300 | Clindamycin hydrochloride | Clindamycin hydrochloride | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0904-5959 | Clindamycin hydrochloride | Clindamycin hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-5959 | Clindamycin hydrochloride | Clindamycin hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-5959 | Clindamycin hydrochloride | Clindamycin hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 10544-153 | Clindamycin hydrochloride | Clindamycin hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 12634-092 | Clindamycin hydrochloride | Clindamycin hydrochloride | Apotheca Inc. | ANDA | Current |
| 21695-033 | clindamycin hydrochloride | clindamycin hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 21695-034 | clindamycin hydrochloride | clindamycin hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 33261-159 | Clindamycin hydrochloride | Clindamycin hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-448 | Clindamycin hydrochloride | Clindamycin hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 50090-0967 | Clindamycin hydrochloride | Clindamycin hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1985 | Clindamycin hydrochloride | Clindamycin hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-1985 | Clindamycin hydrochloride | Clindamycin hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51407-373 | Clindamycin hydrochloride | Clindamycin hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-373 | Clindamycin hydrochloride | Clindamycin hydrochloride | Golden State Medical Supply | ANDA | Current |
| 51407-373 | Clindamycin hydrochloride | Clindamycin hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 51655-964 | Clindamycin hydrochloride | Clindamycin hydrochloride | Northwind Pharmaceuticals | ANDA | Current |
| 53002-0620 | Clindamycin hydrochloride | Clindamycin hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-0620 | Clindamycin hydrochloride | Clindamycin hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55154-7276 | Clindamycin hydrochloride | Clindamycin hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55154-7276 | Clindamycin hydrochloride | Clindamycin hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7276 | Clindamycin hydrochloride | Clindamycin hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7276 | Clindamycin hydrochloride | Clindamycin hydrochloride | Cardinal Health | ANDA | Current |
| 55154-7276 | Clindamycin hydrochloride | Clindamycin hydrochloride | Cardinal Health | ANDA | Current |
| 55700-155 | Clindamycin hydrochloride | Clindamycin hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-155 | Clindamycin hydrochloride | Clindamycin hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-328 | Clindamycin hydrochloride | Clindamycin hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 58118-6920 | Clindamycin hydrochloride | Clindamycin hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-6920 | Clindamycin hydrochloride | Clindamycin hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-6920 | Clindamycin hydrochloride | Clindamycin hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-6920 | Clindamycin hydrochloride | Clindamycin hydrochloride | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60760-484 | Clindamycin hydrochloride | Clindamycin hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-484 | Clindamycin hydrochloride | Clindamycin hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-484 | Clindamycin hydrochloride | Clindamycin hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-057 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Direct Rx | ANDA | Current |
| 61919-057 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-057 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-057 | Clindamycin Hydrochloride | Clindamycin Hydrochloride | Direct Rx | ANDA | Current |
| 61919-441 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-441 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-441 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-441 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-441 | CLINDAMYCIN HYDROCHLORIDE | CLINDAMYCIN HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 63187-141 | Clindamycin hydrochloride | Clindamycin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-141 | Clindamycin hydrochloride | Clindamycin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-141 | Clindamycin hydrochloride | Clindamycin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-141 | Clindamycin hydrochloride | Clindamycin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-141 | Clindamycin hydrochloride | Clindamycin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-141 | Clindamycin hydrochloride | Clindamycin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-247 | Clindamycin hydrochloride | Clindamycin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-247 | Clindamycin hydrochloride | Clindamycin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-247 | Clindamycin hydrochloride | Clindamycin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-247 | Clindamycin hydrochloride | Clindamycin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-247 | Clindamycin hydrochloride | Clindamycin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-247 | Clindamycin hydrochloride | Clindamycin hydrochloride | Proficient Rx LP | ANDA | Current |
| 63304-692 | Clindamycin hydrochloride | Clindamycin hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-692 | Clindamycin hydrochloride | Clindamycin hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-692 | Clindamycin hydrochloride | Clindamycin hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-692 | Clindamycin hydrochloride | Clindamycin hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-692 | Clindamycin hydrochloride | Clindamycin hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-692 | Clindamycin hydrochloride | Clindamycin hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-693 | Clindamycin hydrochloride | Clindamycin hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-693 | Clindamycin hydrochloride | Clindamycin hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-693 | Clindamycin hydrochloride | Clindamycin hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-693 | Clindamycin hydrochloride | Clindamycin hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-693 | Clindamycin hydrochloride | Clindamycin hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63304-693 | Clindamycin hydrochloride | Clindamycin hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 63629-6447 | Clindamycin hydrochloride | Clindamycin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6447 | Clindamycin hydrochloride | Clindamycin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7725 | Clindamycin hydrochloride | Clindamycin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7725 | Clindamycin hydrochloride | Clindamycin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7952 | Clindamycin hydrochloride | Clindamycin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7952 | Clindamycin hydrochloride | Clindamycin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8043 | Clindamycin hydrochloride | Clindamycin hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 66267-060 | Clindamycin hydrochloride | Clindamycin hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-060 | Clindamycin hydrochloride | Clindamycin hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-774 | Clindamycin hydrochloride | Clindamycin hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-774 | Clindamycin hydrochloride | Clindamycin hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67046-083 | Clindamycin hydrochloride | Clindamycin hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30644 | ORIG | 2001-02-02 |