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N019737-001	METROGEL	METRONIDAZOLE	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22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N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`84e616aacf4f…`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N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`caaa826d4ba7…`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UTC	2026-02	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`011fe1cb6892…`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of this ZIP	2025-12	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`31067a03dcf5…`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UTC	2025-08	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`6a471c1ec25d…`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 5 of 8 · 147 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	Baxter Healthcare Corporation	9d762edb-12ac-429d-b1f0-7af5d3b909d4	2025-06-12	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Golden State Medical Supply, Inc.	a6ceb47b-d0b0-d377-e053-2995a90a463e	2025-06-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Golden State Medical Supply, Inc.	a6ce16b7-25c5-48aa-e053-2a95a90aa947	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	b1d13c9f-cf8e-4646-e053-2a95a90a4a35	2025-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Redpharm Drug, inc.	f426cddc-8b70-c0a7-e053-2995a90a74e0	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	AMICI PHARMA INC	9f1fec88-097f-42b9-a36f-214648d7eebb	2025-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	AMICI PHARMA INC	4920fcf7-5ceb-46e9-82e0-dc508900bb91	2025-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Limited	e43b880b-ce69-4f56-9c1c-9c7ca23bba84	2025-03-18	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Inc.	f9b4c86c-932b-4b43-ab1a-6d9e07958044	2025-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals, Inc.	4ab90d8e-c21f-65ac-e054-00144ff8d46c	2025-02-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole vaginal	METRONIDAZOLE	Saptalis Pharmaceuticals LLC	08abacec-3b6a-43e7-bfaa-2041d87a26c7	2025-01-14	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	a860b097-7447-a3b7-e053-2995a90a4bfd	2024-12-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Quality Care Products LLC	0d8125d6-173f-4498-85a9-a1323c7a0e42	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Viona Pharmaceuticals Inc	93299502-6cb0-48a4-8190-50fef74bdbee	2024-12-06	Adverse reactions	Name fallback generic name: METRONIDAZOLE
METRONIDAZOLE	METRONIDAZOLE	Prasco Laboratories	a6ce81f5-a5c6-44d7-b5f0-61d0530345bd	2024-11-07	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	e1e7e127-e99e-80e9-1606-71261658b0c1	2024-11-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	2fa14353-45df-429c-8759-7d66a65f08f0	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
METRONIDAZOLE	METRONIDAZOLE	Mayne Pharma Inc.	567c7c0c-ffc1-47c1-b0fb-8715bf3d76b9	2024-10-31	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Mayne Pharma Inc.	3c25a3f9-52fc-448e-a044-f63b9dadcd4a	2024-10-31	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	8522493d-0a18-49dd-8d49-bd159f6ee332	2024-10-31	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