Application 214604

Type: ANDA
Sponsor: GAGE DEVELOPMENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	LOTION;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
A214604-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB		2021-03-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214604-001	AB

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
2026-08-18 06:07:40	2026-07	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214604-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	LOTION / TOPICAL	AB	2021-03-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A214604-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214604-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214604-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214604-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214604-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214604-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214604-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214604-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214604-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214604-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214604-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214604-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214604-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214604-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214604-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214604-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214604-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214604-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214604-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214604-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214604-001	AB	1	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214604-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214604-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214604-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214604-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214604-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214604-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214604-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214604-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214604-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214604-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214604-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214604-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214604-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214604-001	AB	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 · 5 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	5c08f86e-abd7-4717-b902-74ea336ce28a	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214604 application number: ANDA214604
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	654477df-5cbb-491a-8aec-651598b76884	2025-10-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214604 application number: ANDA214604
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	00fe3546-a166-412f-a543-0ae7763c0ca0	2024-03-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214604 application number: ANDA214604 ndc (product): 63629-8632
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	ac50088c-ba8c-4cca-a473-83011af80e85	2024-01-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214604 application number: ANDA214604 ndc (product): 63629-9459
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	a10dda0c-28fa-4678-8cea-a6ce2fce4b52	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214604 application number: ANDA214604 ndc (product): 45802-128

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-128	Clindamycin Phosphate	clindamycin phosphate	Perrigo New York Inc	ANDA	Current
45802-128	Clindamycin Phosphate	clindamycin phosphate	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
63629-8632	Clindamycin Phosphate	clindamycin phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8632	Clindamycin Phosphate	clindamycin phosphate	Bryant Ranch Prepack	ANDA	Current
63629-8632	Clindamycin Phosphate	clindamycin phosphate	Bryant Ranch Prepack	ANDA	Current
63629-9459	Clindamycin Phosphate	clindamycin phosphate	Bryant Ranch Prepack	ANDA	Current