Application 020743

Type: NDA
Sponsor: VALEANT PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NORITATE	METRONIDAZOLE	CREAM;TOPICAL	1%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020743-001	NORITATE	METRONIDAZOLE	1%	CREAM / TOPICAL		RLD, RS	1997-09-26

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020743-001	NORITATE	1%	CREAM / TOPICAL	RLD, RS	1997-09-26	`cb3db0bc1861…`

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
Metronidazole	METRONIDAZOLE	Oceanside Pharmaceuticals	cdf2e251-4bbc-4434-9b00-bef6284491e4	2022-06-21	Adverse reactions	Exact identifier application applno (NDA): 020743 application number: NDA020743
Noritate	METRONIDAZOLE	Bausch Health US, LLC	706b09da-6cf9-421d-8e91-f3999474d322	2020-06-01	Adverse reactions	Exact identifier application applno (NDA): 020743 application number: NDA020743 ndc (product): 0187-5202

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
0187-5202	Noritate	metronidazole	Bausch Health US, LLC	NDA	Current
0187-5202	Noritate	metronidazole	Valeant Pharmaceuticals North America LLC	NDA	Current
0187-5202	Noritate	metronidazole	Bausch Health US, LLC	NDA	Current
0187-5202	Noritate	metronidazole	Bausch Health US, LLC	NDA	Current
0187-5202	Noritate	metronidazole	Bausch Health US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
3248	SUPPL	2004-07-06
41638	ORIG	2003-08-07
3247	SUPPL	2003-04-18
13329	SUPPL	2003-04-04