Application 065049

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	SWAB;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
A065049-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065049-001	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	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT		2000-05-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065049-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SWAB / TOPICAL	AT	RS	2000-05-25	`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	A065049-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065049-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065049-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065049-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065049-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065049-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065049-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065049-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065049-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065049-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065049-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065049-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065049-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065049-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065049-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065049-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065049-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065049-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065049-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065049-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065049-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065049-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065049-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065049-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065049-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065049-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065049-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065049-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065049-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065049-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065049-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065049-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065049-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065049-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065049-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065049-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065049-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065049-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A065049-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A065049-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindacin P	CLINDAMYCIN PHOSPHATE	Eurofarma, Inc.	288371ef-96b6-4ce3-9be1-1d9d309b400c	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065049 application number: ANDA065049 ndc (product): 43538-170
Clindacin ETZ	CLINDAMYCIN PHOSPHATE	Eurofarma, Inc.	89fed26e-1cad-4c0b-8695-d6f3562ba8d5	2026-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065049 application number: ANDA065049 ndc (product): 43538-172
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	e492d645-7d2e-4f8a-a43a-9999456e9f72	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065049 application number: ANDA065049 ndc (product): 45802-263
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	9cf27a58-6c5f-4a02-88cc-b5ce3ecd8751	2024-01-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065049 application number: ANDA065049 ndc (product): 50090-1932

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
43538-170	Clindacin P	clindamycin phosphate	Medimetriks Pharmaceuticals, Inc.	ANDA	Current
43538-170	Clindacin P	clindamycin phosphate	Medimetriks Pharmaceuticals, Inc.	ANDA	Current
43538-171	Clindacin PAC	clindamycin phosphate	Medimetriks Pharmaceuticals, Inc.	ANDA	Current
43538-172	Clindacin ETZ	clindamycin phosphate	Medimetriks Pharmaceuticals, Inc.	ANDA	Current
43538-173	Clindacin ETZ	clindamycin phosphate	Medimetriks Pharmaceuticals, Inc.	ANDA	Current
45802-263	Clindamycin Phosphate	Clindamycin Phosphate	Perrigo New York Inc	ANDA	Current
45802-263	Clindamycin Phosphate	Clindamycin Phosphate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
45802-263	Clindamycin Phosphate	Clindamycin Phosphate	Perrigo New York Inc	ANDA	Current
45802-263	Clindamycin Phosphate	Clindamycin Phosphate	Perrigo New York Inc	ANDA	Current
45802-263	Clindamycin Phosphate	Clindamycin Phosphate	Perrigo New York Inc	ANDA	Current
50090-1932	Clindamycin Phosphate	Clindamycin Phosphate	A-S Medication Solutions	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42804	ORIG	2003-08-27
30636	ORIG	2000-05-25