Application 203343

Type: ANDA
Sponsor: VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	SOLUTION;TOPICAL	EQ 1% BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203343-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL			2015-05-29

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2015-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2015-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2015-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2015-05-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203343-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		2015-05-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203343-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A203343-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203343-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203343-001	AT	1	`ea99ee380514…`

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.

Matched openFDA labels page 2 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	311c05c2-a2b2-4051-b0b9-0427015aa980	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN PHOSPHATE generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Rising Pharma Holdings, Inc.	cc8262fe-8e41-49b2-97ae-7985e9a894e9	2026-03-24	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Cleocin	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	3db26227-208d-4fdd-8426-1d9be5cda9b4	2026-03-09	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	5c08f86e-abd7-4717-b902-74ea336ce28a	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE GEL USP, 1%	Encube Ethicals, Inc.	ac21d7ad-f94e-4d57-95e3-1648add7ad0b	2026-02-25	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate
XACIATO	CLINDAMYCIN PHOSPHATE	Organon LLC	0423007f-28fa-4159-bf58-9174626d2347	2026-02-19	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin	CLINDAMYCIN PHOSPHATE	Henry Schein, Inc.	8a4e2ba4-90e6-48e8-a943-0c5d3f169780	2026-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE USP, 1%	A-S Medication Solutions	193a4b02-910f-46b2-8b61-25efea694720	2026-02-02	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	GLENMARK PHARMACEUTICALS INC., USA	d0ec3e88-40d9-4919-afc3-cf2e7e863376	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: 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	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	GLENMARK PHARMACEUTICALS INC., USA	d36bad26-f337-4a71-a6e5-d97b60f4e385	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: 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	Name fallback brand name: clindamycin phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Sun Pharmaceutical Industries, Inc.	80c40d1a-2541-4164-8ccb-1b512a851734	2026-01-25	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Viona Pharmaceuticals Inc	585e8b72-b350-451f-a232-199b1a01e8ce	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Encube Ethicals, Inc.	ba6ae5da-affa-422b-9a53-28f3fc001523	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE TOPICAL	Carnegie Pharmaceuticals, LLC	c8fe61f1-f3c5-4452-9980-a727461b9844	2025-12-15	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate
clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Mylan Pharmaceuticals Inc.	f7480256-8b32-419a-8983-e2c413040dba	2025-12-12	Warnings, Adverse reactions	Name fallback brand name: clindamycin phosphate generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Alembic Pharmaceuticals Inc.	96434354-a646-4869-92a2-4052d3f7a4aa	2025-12-02	Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN PHOSPHATE generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	e492d645-7d2e-4f8a-a43a-9999456e9f72	2025-11-30	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10200	ORIG	2015-06-02