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 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
N019737-001	METROGEL	METRONIDAZOLE	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22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 · 43 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
2026-09-14 22:38:34	2026-08	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`caaa826d4ba7…`
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UTC	2026-02	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`011fe1cb6892…`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of this ZIP	2025-12	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`31067a03dcf5…`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UTC	2025-08	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`6a471c1ec25d…`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…`

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 4 of 8 · 147 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	2a5af710-dbf7-41c1-9b3a-35e69b3fa4ab	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	9a18debb-3bb8-4b23-949b-aaa0f3b62191	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Vandazole	METRONIDAZOLE	Upsher-smith Laboratories, LLC	27d71471-8f89-4a1e-8c55-020a58961454	2025-12-02	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Civica, Inc.	902ab25b-d493-495a-884e-96b080e9f72d	2025-11-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Hospira, Inc.	49360d6f-c8b3-420e-af75-154cf7b05255	2025-11-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	ac7e80ce-6174-4246-a955-a92adc516571	2025-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole vaginal	METRONIDAZOLE	A-S Medication Solutions	58ce793b-9b6a-4cd7-94ae-215dbf9e2ef7	2025-10-29	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	353b7f5b-4bbc-4ec9-84ba-d82656ea1811	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole Vaginal Gel, 0.75%	METRONIDAZOLE	Encube Ethicals, Inc.	63ed1e7e-d264-4e35-af83-ec37fa5b06d1	2025-10-09	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	8f1de4ca-a005-4ca9-a43a-380429c80d6f	2025-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	4cdd7ac5-a52c-4766-afeb-1b5e567a328c	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	aea4e2a1-2089-40dc-9eee-deaab4f21397	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	PD-Rx Pharmaceuticals, Inc.	b85bdc1f-1ffb-40d5-a407-e8de2891996d	2025-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	1abb2827-67e4-43c0-9762-8261f480fc3a	2025-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Cadila Pharmaceuticals Limited	0c55bfc1-770a-4cce-a5dd-446000b24f16	2025-09-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	356579f3-a9ed-49cf-bc0d-47b58a58cf85	2025-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Sagent Pharmaceuticals	d46870f5-e2b1-46bd-8413-4a0a8bcf3175	2025-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Amneal Pharmaceuticals Private Limited	843447a5-525c-48ea-860a-230db549fecb	2025-07-17	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Aurobindo Pharma Limited	0b6f6fbd-0292-4c48-a4ae-c24b5f0c8f74	2025-07-11	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Baxter Healthcare Corporation	d2112f37-5080-4a19-bcc3-6386b49abe1d	2025-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE

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 · 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