Application 063329
- Type
- ANDA
- Sponsor
- PADDOCK LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLINDA-DERM | CLINDAMYCIN PHOSPHATE | SOLUTION;TOPICAL | EQ 1% BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A063329-001 | CLINDA-DERM | CLINDAMYCIN PHOSPHATE | EQ 1% BASE | SOLUTION / TOPICAL | 1992-09-30 |
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 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A063329-001 | CLINDA-DERM | EQ 1% BASE | SOLUTION / TOPICAL | AT | 1992-09-30 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A063329-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A063329-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A063329-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A063329-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A063329-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A063329-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A063329-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A063329-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A063329-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A063329-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A063329-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A063329-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A063329-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A063329-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A063329-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A063329-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A063329-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A063329-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A063329-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A063329-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A063329-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A063329-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A063329-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A063329-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A063329-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A063329-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A063329-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A063329-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A063329-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A063329-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A063329-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A063329-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A063329-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A063329-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A063329-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A063329-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A063329-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A063329-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A063329-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A063329-001 | AT | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Cleocin Phosphate | CLINDAMYCIN PHOSPHATE | Pharmacia & Upjohn Company LLC | 05a75685-0af5-407c-ac57-e380c882b49d | 2026-07-29 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Sun Pharmaceutical Industries, Inc. | 9dd8b4f9-9db8-4a16-abcd-bf32219e0301 | 2026-07-14 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Viona Pharmaceuticals Inc | 3f7a3eaa-0f10-4cbe-b035-0796413308d5 | 2026-07-02 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Bryant Ranch Prepack | 25706fd8-d5e2-488b-9888-ee76d2686e19 | 2026-06-12 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Bryant Ranch Prepack | 576fbdf8-b44d-49bf-a569-601861cc402d | 2026-06-12 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindacin P | CLINDAMYCIN PHOSPHATE | Eurofarma, Inc. | 288371ef-96b6-4ce3-9be1-1d9d309b400c | 2026-06-10 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | NORTHSTAR RX LLC | 62e1661f-1eab-4693-8cce-c22f572baa7f | 2026-06-09 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Bryant Ranch Prepack | 27747e01-85eb-44de-a4a6-711a7799218a | 2026-05-29 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin phosphate | CLINDAMYCIN PHOSPHATE | Baxter Healthcare Corporation | 1a42c3b2-90b5-4a78-9f18-fa789742b033 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin phosphate | CLINDAMYCIN PHOSPHATE | Baxter Healthcare Company | 406534a6-2234-4735-ba8f-7de4c87592e6 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Cleocin Phosphate | CLINDAMYCIN PHOSPHATE | Pharmacia & Upjohn Company LLC | a0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b | 2026-05-13 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | Aurobindo Pharma Limited | d4b88e7b-acac-409a-8442-010ef84f66b9 | 2026-04-30 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Padagis Israel Pharmaceuticals Ltd | 461ab478-3cf6-4e9b-ba7d-0331b379cacf | 2026-04-28 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| clindamycin phosphate | CLINDAMYCIN PHOSPHATE | Baxter Healthcare Company | 44fa506b-90ac-42de-831b-5f3f1a500fc0 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin phosphate | CLINDAMYCIN PHOSPHATE | Baxter Healthcare Company | 78832ac6-04c5-45e0-ae4d-f56d7920dda9 | 2026-04-28 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Sun Pharmaceutical Industries, Inc. | 5b8a6767-2d46-401c-9f85-d427dda9eff7 | 2026-04-24 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Bryant Ranch Prepack | c22fb382-afbc-4b2d-bdce-e97e21bddb23 | 2026-04-14 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindacin ETZ | CLINDAMYCIN PHOSPHATE | Eurofarma, Inc. | 89fed26e-1cad-4c0b-8695-d6f3562ba8d5 | 2026-04-02 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Bryant Ranch Prepack | 34f7a271-c012-6463-e063-6394a90ad1ea | 2026-03-31 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Preferred Pharmaceuticals Inc | e06d419f-4b60-405b-9459-e01bbb8d151d | 2026-03-30 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |