Application 214251

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	GEL;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
A214251-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1		2021-02-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A214251-001	AB1

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 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	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB	2021-02-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB	2021-02-10	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214251-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2021-02-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A214251-001	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214251-001	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214251-001	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214251-001	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214251-001	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214251-001	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214251-001	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214251-001	AB1	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214251-001	AB1	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214251-001	AB1	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214251-001	AB1	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214251-001	AB1	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214251-001	AB1	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214251-001	AB1	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214251-001	AB1	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214251-001	AB1	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214251-001	AB1	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214251-001	AB1	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214251-001	AB1	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214251-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214251-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214251-001	AB1	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214251-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214251-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214251-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214251-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214251-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214251-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214251-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214251-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214251-001	AB1	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214251-001	AB1	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214251-001	AB1	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214251-001	AB1	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214251-001	AB1	1	`a50c72e98297…`

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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	NORTHSTAR RX LLC	62e1661f-1eab-4693-8cce-c22f572baa7f	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214251 application number: ANDA214251 ndc (product): 16714-161
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	GLENMARK PHARMACEUTICALS INC., USA	d36bad26-f337-4a71-a6e5-d97b60f4e385	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214251 application number: ANDA214251 ndc (product): 68462-866
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	c205b9e8-3f62-4176-be4e-bc4b5dbf3893	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214251 application number: ANDA214251 ndc (product): 50090-6072

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-161	Clindamycin Phosphate	Clindamycin Phosphate	NORTHSTAR RX LLC	ANDA	Current
50090-6072	Clindamycin Phosphate	Clindamycin Phosphate	A-S Medication Solutions	ANDA	Current
68462-866	Clindamycin Phosphate	Clindamycin Phosphate	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-866	Clindamycin Phosphate	Clindamycin Phosphate	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current