Application 208767

Type: ANDA
Sponsor: CADILA

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 42.

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
A208767-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		2018-07-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208767-001	AT

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 · 42 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
2026-08-18 06:07:40	2026-07	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208767-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	2018-07-16	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A208767-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208767-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208767-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208767-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208767-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208767-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208767-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208767-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208767-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208767-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208767-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208767-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208767-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208767-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208767-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208767-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208767-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208767-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208767-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208767-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208767-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208767-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208767-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208767-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208767-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208767-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208767-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208767-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208767-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208767-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208767-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208767-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208767-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208767-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208767-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208767-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208767-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208767-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208767-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208767-001	AT	1	`e64feba35796…`

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	Preferred Pharmaceuticals Inc	e06d419f-4b60-405b-9459-e01bbb8d151d	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208767 application number: ANDA208767 ndc (product): 68788-7990
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Viona Pharmaceuticals Inc	585e8b72-b350-451f-a232-199b1a01e8ce	2026-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208767 application number: ANDA208767 ndc (product): 72578-084
Clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Zydus Lifesciences Limited	f1f7fb55-1676-4b9e-9f2f-9eaaf33a7633	2024-08-14		Exact identifier application applno (ANDA): 208767 application number: ANDA208767 ndc (product): 70771-1414

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
53002-8371	Clindamycin Phosphate	Clindamycin Phosphate	RPK Pharmaceuticals, Inc.	ANDA	Current
68788-7990	Clindamycin Phosphate	Clindamycin Phosphate	Preferred Pharmaceuticals Inc	ANDA	Current
68788-7990	Clindamycin Phosphate	Clindamycin Phosphate	Preferred Pharmaceuticals Inc	ANDA	Current
70710-1231	Clindamycin phosphate	Clindamycin phosphate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1231	Clindamycin phosphate	Clindamycin phosphate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70710-1231	Clindamycin phosphate	Clindamycin phosphate	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1414	Clindamycin phosphate	Clindamycin phosphate	Cadila Healthcare Limited	ANDA	Current
70771-1414	Clindamycin phosphate	Clindamycin phosphate	Zydus Lifesciences Limited	ANDA	Current
70771-1414	Clindamycin phosphate	Clindamycin phosphate	Cadila Healthcare Limited	ANDA	Current
70771-1414	Clindamycin phosphate	Clindamycin phosphate	Cadila Healthcare Limited	ANDA	Current
72578-084	Clindamycin Phosphate	Clindamycin Phosphate	Viona Pharmaceuticals Inc	ANDA	Current
72578-084	Clindamycin Phosphate	Clindamycin Phosphate	Viona Pharmaceuticals Inc	ANDA	Current