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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
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	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Sun Pharmaceutical Industries, Inc.	9dd8b4f9-9db8-4a16-abcd-bf32219e0301	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Viona Pharmaceuticals Inc	3f7a3eaa-0f10-4cbe-b035-0796413308d5	2026-07-02	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	25706fd8-d5e2-488b-9888-ee76d2686e19	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	576fbdf8-b44d-49bf-a569-601861cc402d	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindacin P	CLINDAMYCIN PHOSPHATE	Eurofarma, Inc.	288371ef-96b6-4ce3-9be1-1d9d309b400c	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	NORTHSTAR RX LLC	62e1661f-1eab-4693-8cce-c22f572baa7f	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	27747e01-85eb-44de-a4a6-711a7799218a	2026-05-29	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Corporation	1a42c3b2-90b5-4a78-9f18-fa789742b033	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Company	406534a6-2234-4735-ba8f-7de4c87592e6	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin phosphate generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Pharmacia & Upjohn Company LLC	a0a2eff7-b7de-42fe-8e5a-0cfbed38bb4b	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Aurobindo Pharma Limited	d4b88e7b-acac-409a-8442-010ef84f66b9	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN PHOSPHATE generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	461ab478-3cf6-4e9b-ba7d-0331b379cacf	2026-04-28	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Company	44fa506b-90ac-42de-831b-5f3f1a500fc0	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: clindamycin phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Baxter Healthcare Company	78832ac6-04c5-45e0-ae4d-f56d7920dda9	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Clindamycin phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Sun Pharmaceutical Industries, Inc.	5b8a6767-2d46-401c-9f85-d427dda9eff7	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	c22fb382-afbc-4b2d-bdce-e97e21bddb23	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindacin ETZ	CLINDAMYCIN PHOSPHATE	Eurofarma, Inc.	89fed26e-1cad-4c0b-8695-d6f3562ba8d5	2026-04-02	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	34f7a271-c012-6463-e063-6394a90ad1ea	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE 1%	Preferred Pharmaceuticals Inc.	ea8d75ef-0e9b-4177-99f7-c901eb44f888	2026-03-30	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate

Documents#

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