Application 064050

Type: ANDA
Sponsor: PERRIGO NEW YORK

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
A064050-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064050-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		1995-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		1995-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		1995-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		1995-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		1995-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT		1995-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064050-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	RS	1995-11-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A064050-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064050-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064050-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064050-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064050-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064050-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064050-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064050-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064050-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064050-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064050-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064050-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064050-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064050-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064050-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064050-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064050-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064050-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064050-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064050-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064050-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064050-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064050-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064050-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064050-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064050-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064050-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064050-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064050-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064050-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064050-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064050-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064050-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064050-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064050-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064050-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064050-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064050-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064050-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064050-001	AT	1	`cb3db0bc1861…`

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 · 7 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	25706fd8-d5e2-488b-9888-ee76d2686e19	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	576fbdf8-b44d-49bf-a569-601861cc402d	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	27747e01-85eb-44de-a4a6-711a7799218a	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050 ndc (product): 63629-8633
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	461ab478-3cf6-4e9b-ba7d-0331b379cacf	2026-04-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050 ndc (product): 45802-562
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	c22fb382-afbc-4b2d-bdce-e97e21bddb23	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050 ndc (product): 63629-8634
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	34f7a271-c012-6463-e063-6394a90ad1ea	2026-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	ba3f54e5-1ff5-4ffd-8ed2-f15439f423e9	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 064050 application number: ANDA064050 ndc (product): 50090-2611

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-562	Clindamycin Phosphate	Clindamycin Phosphate	Perrigo New York Inc	ANDA	Current
45802-562	Clindamycin Phosphate	Clindamycin Phosphate	Perrigo New York Inc	ANDA	Current
45802-562	Clindamycin Phosphate	Clindamycin Phosphate	Perrigo New York Inc	ANDA	Current
45802-562	Clindamycin Phosphate	Clindamycin Phosphate	Perrigo New York Inc	ANDA	Current
45802-562	Clindamycin Phosphate	Clindamycin Phosphate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-562	Clindamycin Phosphate	Clindamycin Phosphate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
50090-2611	Clindamycin Phosphate	Clindamycin Phosphate	A-S Medication Solutions	ANDA	Current
50090-2611	Clindamycin Phosphate	Clindamycin Phosphate	A-S Medication Solutions	ANDA	Current
50090-2611	Clindamycin Phosphate	Clindamycin Phosphate	A-S Medication Solutions	ANDA	Current
53002-8370	Clindamycin Phosphate	Clindamycin Phosphate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-8370	Clindamycin Phosphate	Clindamycin Phosphate	RPK Pharmaceuticals, Inc.	ANDA	Current
63629-8633	Clindamycin Phosphate	Clindamycin Phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8633	Clindamycin Phosphate	Clindamycin Phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8633	Clindamycin Phosphate	Clindamycin Phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8633	Clindamycin Phosphate	Clindamycin Phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8634	Clindamycin Phosphate	Clindamycin Phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8634	Clindamycin Phosphate	Clindamycin Phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8634	Clindamycin Phosphate	Clindamycin Phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8634	Clindamycin Phosphate	Clindamycin Phosphate	Bryant Ranch Prepack	ANDA	Current
68788-6959	Clindamycin Phosphate	Clindamycin Phosphate	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6959	Clindamycin Phosphate	Clindamycin Phosphate	Preferred Pharmaceuticals Inc.	ANDA	Current
72275-741	Clindavix	Clindamycin Phosphate, Dimethicone	Primary Pharmaceuticals, Inc.	ANDA	Current