Application 050782

Type: NDA
Sponsor: BAUSCH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDAGEL	CLINDAMYCIN PHOSPHATE	GEL;TOPICAL	EQ 1% BASE	Yes	Yes

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
N050782-001	CLINDAGEL	CLINDAMYCIN PHOSPHATE	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N050782-001	AB2

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 · 42 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
2026-08-18 06:07:40	2026-07	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	BT	RLD, RS	2000-11-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	BT	RLD, RS	2000-11-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	BT	RLD, RS	2000-11-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	BT	RLD, RS	2000-11-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	BT	RLD, RS	2000-11-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	BT	RLD, RS	2000-11-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	BT	RLD, RS	2000-11-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	BT	RLD, RS	2000-11-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050782-001	CLINDAGEL	EQ 1% BASE	GEL / TOPICAL	AB2	RLD, RS	2000-11-27	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N050782-001	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050782-001	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050782-001	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050782-001	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050782-001	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050782-001	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050782-001	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050782-001	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050782-001	AB2	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050782-001	AB2	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050782-001	AB2	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050782-001	AB2	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050782-001	AB2	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050782-001	AB2	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050782-001	AB2	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050782-001	AB2	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050782-001	AB2	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050782-001	AB2	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050782-001	BT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050782-001	AB2	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050782-001	AB2	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050782-001	BT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050782-001	BT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050782-001	BT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050782-001	BT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050782-001	BT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050782-001	BT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050782-001	BT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050782-001	AB2	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050782-001	AB2	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050782-001	AB2	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050782-001	AB2	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050782-001	AB2	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050782-001	AB2	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050782-001	AB2	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050782-001	AB2	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050782-001	AB2	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050782-001	AB2	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050782-001	AB2	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050782-001	AB2	1	`e64feba35796…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050782-001	6387383	2020-08-03	U-818	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N050782-001	6387383	2020-08-03	U-818	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050782-001	6387383	2020-08-03	U-818	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050782-001	6387383	2020-08-03	U-818	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050782-001	6387383	2020-08-03	U-818	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050782-001	6387383	2020-08-03	U-818	Drug product	`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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindamycin Phosphate	CLINDAMYCIN PHOSPHATE	Oceanside Pharmaceuticals	7fd5e0a2-159b-4147-947e-944eeebc1783	2024-11-11	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050782 application number: NDA050782 ndc (product): 68682-462
Clindagel	CLINDAMYCIN	Bausch Health US, LLC	f7b4e985-719a-4547-b624-94612d520991	2020-01-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050782 application number: NDA050782 ndc (product): 16781-462

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16781-462	Clindagel	CLINDAMYCIN	Bausch Health US LLC	NDA	Current
16781-462	Clindagel	CLINDAMYCIN	Bausch Health US, LLC	NDA	Current
16781-462	Clindagel	CLINDAMYCIN	Onset Dermatologics LLC	NDA	Current
68682-462	Clindamycin Phosphate	Clindamycin Phosphate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-462	Clindamycin Phosphate	Clindamycin Phosphate	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22237	ORIG	2004-07-15
39325	ORIG	2003-05-02
30529	ORIG	2000-11-27