Application 203048
- Type
- ANDA
- Sponsor
- AKORN INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | INJECTABLE;INJECTION | EQ 6MG BASE/ML | No | No |
| 002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | INJECTABLE;INJECTION | EQ 12MG BASE/ML | No | No |
| 003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | INJECTABLE;INJECTION | EQ 18MG BASE/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | |
| A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | |
| A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | CLINDAMYCIN PHOSPHATE | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203048-001 | AP |
| A203048-002 | AP |
| A203048-003 | AP |
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 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203048-002 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 12MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203048-003 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 18MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203048-001 | CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER | EQ 6MG BASE/ML | INJECTABLE / INJECTION | AP | 2013-04-04 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A203048-001 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203048-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A203048-003 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A203048-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203048-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A203048-003 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A203048-001 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203048-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203048-003 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203048-001 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203048-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203048-003 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203048-001 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203048-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203048-003 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203048-001 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203048-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203048-003 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203048-001 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203048-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203048-003 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203048-001 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203048-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203048-003 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203048-001 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203048-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203048-003 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203048-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203048-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203048-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203048-001 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203048-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203048-003 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203048-001 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203048-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203048-003 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203048-001 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203048-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A203048-003 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A203048-001 | AP | 1 | 301d65b070ca… |
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 Phosphate | CLINDAMYCIN PHOSPHATE | Preferred Pharmaceuticals Inc | e06d419f-4b60-405b-9459-e01bbb8d151d | 2026-03-30 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | Bryant Ranch Prepack | 311c05c2-a2b2-4051-b0b9-0427015aa980 | 2026-03-30 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Rising Pharma Holdings, Inc. | cc8262fe-8e41-49b2-97ae-7985e9a894e9 | 2026-03-24 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Cleocin | CLINDAMYCIN PHOSPHATE | Pharmacia & Upjohn Company LLC | 3db26227-208d-4fdd-8426-1d9be5cda9b4 | 2026-03-09 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Bryant Ranch Prepack | 5c08f86e-abd7-4717-b902-74ea336ce28a | 2026-03-05 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| XACIATO | CLINDAMYCIN PHOSPHATE | Organon LLC | 0423007f-28fa-4159-bf58-9174626d2347 | 2026-02-19 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin | CLINDAMYCIN PHOSPHATE | Henry Schein, Inc. | 8a4e2ba4-90e6-48e8-a943-0c5d3f169780 | 2026-02-18 | Boxed warning, Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | GLENMARK PHARMACEUTICALS INC., USA | d0ec3e88-40d9-4919-afc3-cf2e7e863376 | 2026-01-29 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 997a23c8-f0d7-49d5-af33-e11f2ddab3c7 | 2026-01-28 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | GLENMARK PHARMACEUTICALS INC., USA | d36bad26-f337-4a71-a6e5-d97b60f4e385 | 2026-01-28 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| clindamycin phosphate | CLINDAMYCIN PHOSPHATE | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | 62a2019f-7410-4251-95ed-181925ade6e4 | 2026-01-28 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Sun Pharmaceutical Industries, Inc. | 80c40d1a-2541-4164-8ccb-1b512a851734 | 2026-01-25 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Viona Pharmaceuticals Inc | 585e8b72-b350-451f-a232-199b1a01e8ce | 2026-01-07 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Encube Ethicals, Inc. | ba6ae5da-affa-422b-9a53-28f3fc001523 | 2026-01-06 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| clindamycin phosphate | CLINDAMYCIN PHOSPHATE | Mylan Pharmaceuticals Inc. | f7480256-8b32-419a-8983-e2c413040dba | 2025-12-12 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| CLINDAMYCIN PHOSPHATE | CLINDAMYCIN PHOSPHATE | Alembic Pharmaceuticals Inc. | 96434354-a646-4869-92a2-4052d3f7a4aa | 2025-12-02 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | Padagis Israel Pharmaceuticals Ltd | e492d645-7d2e-4f8a-a43a-9999456e9f72 | 2025-11-30 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Clindamycin Phosphate | CLINDAMYCIN PHOSPHATE | A-S Medication Solutions | c205b9e8-3f62-4176-be4e-bc4b5dbf3893 | 2025-11-25 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Cleocin T | CLINDAMYCIN PHOSPHATE | Pharmacia & Upjohn Company LLC | 4a3901a4-194f-4a15-9c85-3d0982afcf31 | 2025-11-24 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
| Cleocin | CLINDAMYCIN PHOSPHATE | Pharmacia & Upjohn Company LLC | f9be442d-0782-4b93-828f-9ebbf67dbced | 2025-11-19 | Warnings, Adverse reactions | CLINDAMYCIN PHOSPHATE |
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 |
|---|---|---|---|---|---|
| 17478-120 | Clindamycin | Clindamycin Phosphate | Akorn, Inc. | ANDA | Current |
| 17478-120 | Clindamycin | Clindamycin Phosphate | Akorn | ANDA | Current |
| 17478-120 | Clindamycin | Clindamycin Phosphate | Akorn | ANDA | Current |
| 17478-120 | Clindamycin | Clindamycin Phosphate | Akorn, Inc. | ANDA | Current |
| 17478-120 | Clindamycin | Clindamycin Phosphate | Akorn | ANDA | Current |
| 17478-120 | Clindamycin | Clindamycin Phosphate | Akorn, Inc. | ANDA | Current |
| 17478-120 | Clindamycin | Clindamycin Phosphate | Akorn, Inc. | ANDA | Current |
| 17478-121 | Clindamycin | Clindamycin Phosphate | Akorn, Inc. | ANDA | Current |
| 17478-121 | Clindamycin | Clindamycin Phosphate | Akorn | ANDA | Current |
| 17478-121 | Clindamycin | Clindamycin Phosphate | Akorn | ANDA | Current |
| 17478-121 | Clindamycin | Clindamycin Phosphate | Akorn, Inc. | ANDA | Current |
| 17478-121 | Clindamycin | Clindamycin Phosphate | Akorn | ANDA | Current |
| 17478-121 | Clindamycin | Clindamycin Phosphate | Akorn, Inc. | ANDA | Current |
| 17478-121 | Clindamycin | Clindamycin Phosphate | Akorn, Inc. | ANDA | Current |
| 17478-122 | Clindamycin | Clindamycin Phosphate | Akorn, Inc. | ANDA | Current |
| 17478-122 | Clindamycin | Clindamycin Phosphate | Akorn | ANDA | Current |
| 17478-122 | Clindamycin | Clindamycin Phosphate | Akorn | ANDA | Current |
| 17478-122 | Clindamycin | Clindamycin Phosphate | Akorn, Inc. | ANDA | Current |
| 17478-122 | Clindamycin | Clindamycin Phosphate | Akorn | ANDA | Current |
| 17478-122 | Clindamycin | Clindamycin Phosphate | Akorn, Inc. | ANDA | Current |
| 17478-122 | Clindamycin | Clindamycin Phosphate | Akorn, Inc. | ANDA | Current |