Application 090785

Type: ANDA
Sponsor: PERRIGO UK FINCO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	AEROSOL, FOAM;TOPICAL	1%	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
A090785-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090785-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT	RS	2010-03-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090785-001	CLINDAMYCIN PHOSPHATE	1%	AEROSOL, FOAM / TOPICAL	AT		2010-03-31	`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	A090785-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090785-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090785-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090785-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090785-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090785-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090785-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090785-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090785-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090785-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090785-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090785-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090785-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090785-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090785-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090785-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090785-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090785-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090785-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090785-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090785-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090785-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090785-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090785-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090785-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090785-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090785-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090785-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090785-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090785-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090785-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090785-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090785-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090785-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090785-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090785-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090785-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090785-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090785-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090785-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	a95020e2-9318-4a6b-8931-95771946638d	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090785 application number: ANDA090785 ndc (product): 63629-8628
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	e8086cf9-aa52-4aa5-815b-c76e8f145e0b	2023-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090785 application number: ANDA090785 ndc (product): 63629-8629
Clindacin	CLINDAMYCIN PHOSPHATE	Medimetriks Pharmaceuticals, Inc.	d01ffda3-1913-400d-a899-58b8face8936	2022-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090785 application number: ANDA090785 ndc (product): 43538-179
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	2e6f96d0-d928-4775-a7db-3e998fce675b	2022-04-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090785 application number: ANDA090785 ndc (product): 45802-660

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43538-179	Clindacin	clindamycin phosphate	Medimetriks Pharmaceuticals, Inc.	ANDA	Current
45802-660	Clindamycin Phosphate	clindamycin phosphate	Perrigo New York Inc	ANDA	Current
45802-660	Clindamycin Phosphate	clindamycin phosphate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-660	Clindamycin Phosphate	clindamycin phosphate	Perrigo New York Inc	ANDA	Current
45802-660	Clindamycin Phosphate	clindamycin phosphate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
63629-8628	Clindamycin Phosphate	clindamycin phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8628	Clindamycin Phosphate	clindamycin phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8628	Clindamycin Phosphate	clindamycin phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8629	Clindamycin Phosphate	clindamycin phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8629	Clindamycin Phosphate	clindamycin phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8629	Clindamycin Phosphate	clindamycin phosphate	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22714	ORIG	2012-11-14
9295	ORIG	2010-04-05