Application 215219

Type: ANDA
Sponsor: AMNEAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	GEL;TOPICAL	EQ 1% BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215219-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL			2022-11-03

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
2026-09-14 22:38:34	2026-08	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2022-11-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2022-11-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2022-11-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2022-11-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2022-11-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2022-11-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2022-11-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2022-11-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB1	2022-11-03	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215219-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL		2022-11-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-02-18 07:12 UTC	2024-02	A215219-001	AB1	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215219-001	AB1	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215219-001	AB1	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215219-001	AB1	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215219-001	AB1	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215219-001	AB1	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215219-001	AB1	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215219-001	AB1	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215219-001	AB1	1	`3a93d1ddd44b…`

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 5 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	dc8b8a09-3eed-1998-e053-2995a90a2f60	2023-05-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	6f72b852-e741-48e5-b8e1-f8a1afcfb4d4	2023-02-01	Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN PHOSPHATE generic name: CLINDAMYCIN PHOSPHATE
Clindacin	CLINDAMYCIN PHOSPHATE	Medimetriks Pharmaceuticals, Inc.	d01ffda3-1913-400d-a899-58b8face8936	2022-11-21	Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	2e6f96d0-d928-4775-a7db-3e998fce675b	2022-04-06	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69238-2030	Clindamycin Phosphate	Clindamycin Phosphate	Amneal Pharmaceuticals NY LLC	ANDA	Current