Application 019737

Type: NDA
Sponsor: GALDERMA LABS LP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METROGEL	METRONIDAZOLE	GEL;TOPICAL	0.75%	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
N019737-001	METROGEL	METRONIDAZOLE	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019737-001	METROGEL	0.75%	GEL / TOPICAL		RLD	1988-11-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019737-001	METROGEL	0.75%	GEL / TOPICAL		RLD	1988-11-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019737-001	METROGEL	0.75%	GEL / TOPICAL		RLD	1988-11-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019737-001	METROGEL	0.75%	GEL / TOPICAL		RLD	1988-11-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019737-001	METROGEL	0.75%	GEL / TOPICAL		RLD	1988-11-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019737-001	METROGEL	0.75%	GEL / TOPICAL		RLD	1988-11-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019737-001	METROGEL	0.75%	GEL / TOPICAL		RLD	1988-11-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019737-001	METROGEL	0.75%	GEL / TOPICAL		RLD	1988-11-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019737-001	METROGEL	0.75%	GEL / TOPICAL		RLD	1988-11-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019737-001	METROGEL	0.75%	GEL / TOPICAL		RLD	1988-11-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019737-001	METROGEL	0.75%	GEL / TOPICAL	AB	RLD, RS	1988-11-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	N019737-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019737-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019737-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019737-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019737-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019737-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019737-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019737-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019737-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019737-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019737-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019737-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019737-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019737-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019737-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019737-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019737-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019737-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019737-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019737-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019737-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019737-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019737-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019737-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019737-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019737-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019737-001	AB	1	`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 8 · 150 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	5cc3fd98-d579-432e-a4b5-b6d5586991a6	2026-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	dc28753c-95ec-4b41-ad77-c4a66698d9db	2026-08-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	b49a8ad0-2cf9-4386-8bf5-1b1df87b0022	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	d5784eeb-6b99-4e8a-847b-b0d1090ed48a	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	2f7d84d4-1085-4243-be88-442eecb85205	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Vagizole	METRONIDAZOLE	iNutrition LLC	fd5e884b-cf07-493b-bb93-039bbb0c4784	2026-07-22	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	5cf3cc1f-601e-4997-bfb2-a573c31c8189	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	4a233572-2471-4e99-a45e-2de978abcf16	2026-07-15	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	5a504f74-bccd-433a-bd5b-6822f98c34df	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	5842a554-58d1-4ee4-99aa-1e6029a69be2	2026-07-15	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	4748ba37-9d66-497d-aa9f-ca2d541c5f41	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	59e53582-244a-4e9d-b18e-75dddc6a5052	2026-07-08	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	cfeab9e3-58b9-4890-9185-11b62904e2af	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	cbee69e8-029c-49d2-89cd-f504b8e0ac28	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	3e0a14f1-961b-4722-bfea-aafcc5d7706c	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	53918705-d2fe-4c6b-9501-a619a8ad3991	2026-07-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Kanchan Healthcare Inc	8836334e-6db4-44be-bc9e-099b26322cf4	2026-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	99886f54-4ebe-4a2d-b779-bcfbb0634db1	2026-06-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	49bed450-7fa8-401c-8c8c-afc1c61d473a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	3c0ebb00-a0ae-4f64-9bfc-de01193191e8	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66993-962	Metronidazole Topical Gel	metronidazole	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
69007-835	Metronidazole Topical Gel	metronidazole	Owen Laboratories	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19139	SUPPL	2002-06-03