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N019737-001	METROGEL	METRONIDAZOLE	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22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N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`84e616aacf4f…`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N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`caaa826d4ba7…`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UTC	2026-02	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`011fe1cb6892…`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of this ZIP	2025-12	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`31067a03dcf5…`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UTC	2025-08	N019737-001	METROGEL	0.75% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	GEL / TOPICAL		RLD	1988-11-22	`6a471c1ec25d…`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

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	92e58420-1d99-4a92-b1f3-a7f791ca7187	2024-10-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	e6ece591-38fa-4016-bd62-d31a3e5a8da3	2024-10-21	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
METRONIDAZOLE	METRONIDAZOLE	Aurobindo Pharma Limited	d9d4caed-2fa9-4b46-9b7c-d60ec3b879b2	2024-10-17	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	daee5e69-aa86-470b-81b7-3074d27fc847	2024-10-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Mayne Pharma Inc.	5099691f-f216-4ac1-b057-99a845cc770f	2024-09-30	Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Rising Pharma Holdings, Inc.	93e4f174-4fe0-4cfd-a0cf-d0963e082107	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	8e1f507b-22fa-4033-9b3e-5435f20ace66	2024-09-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Aurobindo Pharma Limited	f68397ee-67db-472e-8607-4300064e37df	2024-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Viona Pharmaceuticals Inc	0f108035-d2ab-49c1-9f8d-daae11f0efe0	2024-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
METRONIDAZOLE	METRONIDAZOLE	Zydus Lifesciences Limited	f3ef765c-b531-4aaa-a86d-e32b7254ca48	2024-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	9e702861-87f5-4bc0-864d-317050020194	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	1030e723-cde9-44a7-8dab-2f0932ffcc2c	2024-08-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	ea635d05-b3c1-4f49-ace2-d091c20920da	2024-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	cdd942a1-fb3b-4912-bd3f-8aef451e6a3c	2024-08-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Unichem Pharmaceuticals (USA), Inc.	9219588b-0a99-40b9-bdd4-ced6d6efebed	2024-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Proficient Rx LP	e313c7d9-fb7b-4d0f-bccf-cc72ac5ef205	2024-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	d9e33638-3803-426e-a1c3-7d0cf145d92f	2024-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	ae2e4bbe-8c12-4af9-e053-2a95a90af299	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	b2bd62c2-c6ed-f459-e053-2a95a90a90eb	2024-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Alembic Pharmaceuticals Inc.	b1fcf023-cdfd-45b7-b4d4-ff814f33ee79	2024-07-17	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