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N019737-001	METROGEL	METRONIDAZOLE	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22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N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`84e616aacf4f…`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N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`caaa826d4ba7…`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UTC	2026-02	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`011fe1cb6892…`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of this ZIP	2025-12	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`31067a03dcf5…`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UTC	2025-08	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`6a471c1ec25d…`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 7 of 8 · 147 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	Teva Pharmaceuticals USA, Inc.	291a45f6-ed27-4dcc-8364-358d08623797	2024-07-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	937913b8-c131-6339-e053-2a95a90a4dd9	2024-06-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	9d41a8b3-b8cc-4fb6-9813-d3bfa048ed78	2024-05-06	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Asclemed USA, Inc.	89970965-a995-4ae4-a70b-bd2de38081e1	2024-04-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Inc.	9f56cc00-6383-48c8-95ee-e6a404a0237b	2024-03-05	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Chartwell RX, LLC	f053ad94-d884-457c-9c35-4e0df1d26eea	2024-02-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	38376be4-4bb3-4647-aedf-bb7bfef053e5	2024-02-29	Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	c2dbfec8-da5b-cd2b-e053-2a95a90ad17c	2024-02-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Cosette Pharmaceuticals, Inc.	de4cb39f-cc6e-98fb-05e5-103f3aca2dad	2023-11-29	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Nuvessa	METRONIDAZOLE	Exeltis USA, Inc.	3b6ff39d-f84b-43b3-9b07-c0521c6d7968	2023-11-10	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	8b2c294b-ed70-447c-bbc4-2a8b59f1aca4	2023-10-25	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole vaginal	METRONIDAZOLE	Padagis Israel Pharmaceuticals Ltd	eb240e7b-cec8-497b-8a49-7ed768e2b431	2023-07-25	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Cosette Pharmaceuticals, Inc.	d76810d5-11b4-4b5e-b850-230f59376c34	2023-07-18	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Zydus Lifesciences Limited	728ebe6d-7a20-481d-845a-ceffa450179f	2023-05-05		Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	bff2f5bd-75a4-4252-a643-c21741ae8a96	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Cosette Pharmaceuticals, Inc.	a0d7d4e8-28c0-4211-8d76-73a173b48d9a	2023-01-31	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Limited	80c79325-1ea4-46f8-b9b8-967b7640c51d	2023-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Limited	d7455566-16aa-488a-af2a-93b55a04c02f	2023-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Limited	387053e5-7eda-4282-b58a-5789430a2e99	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Proficient Rx LP	205054e1-8172-47dc-931c-a18a60e7e9f0	2022-12-01	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