Application 050793

Type: NDA
Sponsor: PERRIGO PHARMA INTL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CLINDESSE	CLINDAMYCIN PHOSPHATE	CREAM;VAGINAL	EQ 2% 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
N050793-001	CLINDESSE	CLINDAMYCIN PHOSPHATE	EQ 2% BASE	CREAM / VAGINAL		RLD, RS	2004-11-30

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N050793-001	CLINDESSE	EQ 2% BASE	CREAM / VAGINAL	RLD, RS	2004-11-30	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050793-001	6899890	2023-04-27	U-137	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N050793-001	6899890	2023-04-27	U-137	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N050793-001	6899890	2023-04-27	U-137	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N050793-001	6899890	2023-04-27	U-137	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050793-001	6899890	2023-04-27	U-137	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050793-001	6899890	2023-04-27	U-137	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050793-001	6899890	2023-04-27	U-137	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050793-001	6899890	2023-04-27	U-137	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050793-001	6899890	2023-04-27	U-137	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050793-001	6899890	2023-04-27	U-137	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050793-001	6899890	2023-04-27	U-137	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050793-001	6899890	2023-04-27	U-137	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050793-001	9789057	2026-12-02	U-137	Drug product	2018-01-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050793-001	6899890	2023-04-27	U-137	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clindesse	CLINDAMYCIN PHOSPHATE	Padagis Israel Pharmaceuticals Ltd	fe8bb204-f173-44fe-803b-b08f2ec5aa31	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 050793 application number: NDA050793 ndc (product): 45802-042

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
45802-042	Clindesse	clindamycin phosphate	Padagis Israel Pharmaceuticals Ltd	NDA	Current
45802-042	Clindesse	clindamycin phosphate	Perrigo New York Inc	NDA	Current
45802-042	Clindesse	clindamycin phosphate	Perrigo New York Inc	NDA	Current
45802-042	Clindesse	clindamycin phosphate	Perrigo New York Inc	NDA	Current
64011-124	Clindesse	clindamycin phosphate	Ther-Rx Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81080	SUPPL	2025-02-06
80992	SUPPL	2025-02-05
76390	SUPPL	2023-11-06
76379	SUPPL	2023-11-06
8301	SUPPL	2012-02-23
39343	SUPPL	2012-02-17
30565	SUPPL	2010-12-21
39342	SUPPL	2010-12-16
42741	ORIG	2006-09-26
30564	ORIG	2004-12-06
18264	ORIG	2004-12-03