Application 062811

Type: ANDA
Sponsor: G AND W LABS INC

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 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
A062811-001	CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL			1988-09-01

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 · 43 observed 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	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	1988-09-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	1988-09-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	1988-09-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL	AT	1988-09-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062811-001	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	SOLUTION / TOPICAL		1988-09-01	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A062811-001	AT	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A062811-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062811-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062811-001	AT	1	`ea99ee380514…`

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 4 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Amneal Pharmaceuticals NY LLC	ea1d4a37-7da2-4228-8451-6367e1a62554	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	00fe3546-a166-412f-a543-0ae7763c0ca0	2024-03-22	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	eddc86b8-2bcc-47ad-a11f-06e00d399a5e	2024-03-13	Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN PHOSPHATE generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	12ee0720-9979-3162-e063-6394a90a8003	2024-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	ac50088c-ba8c-4cca-a473-83011af80e85	2024-01-12	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	9cf27a58-6c5f-4a02-88cc-b5ce3ecd8751	2024-01-07	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
clindamycin phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	d416208c-474e-45c6-b28f-e86a9052edb3	2023-12-07	Warnings, Adverse reactions	Name fallback brand name: clindamycin phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	44759c4f-5c87-4347-800f-83bb7487fff0	2023-12-03	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Zydus Lifesciences Limited	ca60af4c-3296-4ef9-839f-9ddb34a266da	2023-09-20		Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	a10dda0c-28fa-4678-8cea-a6ce2fce4b52	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	A-S Medication Solutions	395d6d51-7093-43d5-8f18-ff5c5a8f8384	2023-08-27	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	bdfa283e-87ca-41bd-9ae1-d6652dcfa7dd	2023-07-17	Warnings, Adverse reactions	Name fallback brand name: CLINDAMYCIN PHOSPHATE generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	a95020e2-9318-4a6b-8931-95771946638d	2023-07-17	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Bryant Ranch Prepack	e8086cf9-aa52-4aa5-815b-c76e8f145e0b	2023-07-17	Warnings, Adverse reactions	Name fallback brand name: Clindamycin Phosphate generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	896a046f-95d0-100e-e053-2a95a90aa59c	2023-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e500a08-0339-eb6b-e053-2a95a90a130c	2023-05-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e4fc2d5-985a-3734-e053-2995a90aef5b	2023-05-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e549ceb-00e8-64b8-e053-2a95a90aef0f	2023-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Clindamycin	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e545c9d-dc39-584c-e053-2995a90afda4	2023-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CLINDAMYCIN PHOSPHATE
Cleocin Phosphate	CLINDAMYCIN PHOSPHATE	Medical Purchasing Solutions, LLC	9e5365a0-dd47-264a-e053-2a95a90a7fb8	2023-05-09	Boxed warning, Warnings, Adverse reactions	Name fallback 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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0472-0987	Clindamycin Phosphate	Clindamycin Phosphate	Actavis Pharma, Inc.	ANDA	Current
45865-902	Clindamycin Phosphate	Clindamycin Phosphate	medsource pharmaceuticals	ANDA	Current
50090-3086	Clindamycin Phosphate	Clindamycin Phosphate	A-S Medication Solutions	ANDA	Current
50090-3086	Clindamycin Phosphate	Clindamycin Phosphate	A-S Medication Solutions	ANDA	Current