Application 077264

Type: ANDA
Sponsor: TOLMAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METRONIDAZOLE	METRONIDAZOLE	GEL;VAGINAL	0.75%	No	No

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
A077264-001	METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL / VAGINAL			2006-10-31

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL		2006-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077264-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2006-10-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077264-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077264-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077264-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077264-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077264-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077264-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077264-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077264-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077264-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077264-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077264-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077264-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077264-001	AB	1	`ea99ee380514…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077264-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077264-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077264-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077264-001	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 2 of 8 · 151 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Flagyl	METRONIDAZOLE	Pfizer Laboratories Div Pfizer Inc	a2883ca1-5a9a-4259-9d80-46ab67274384	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Gland Pharma Limited	74cf111a-9b83-4f93-b0e8-bc252d471d43	2026-05-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	WG Critical Care, LLC	e4ea0c09-cdd1-4708-962c-6ba28b989df3	2026-05-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Method Pharmaceuticals LLC	2ae49bf4-a23b-bdcc-e063-6294a90a80a9	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: metronidazole generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	ST. MARY'S MEDICAL PARK PHARMACY	e3a32908-9db1-6ca7-e053-2a95a90a82fb	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Coupler LLC	509c8d03-e199-8154-e063-6394a90afddc	2026-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
METRONIDAZOLE	METRONIDAZOLE	B. Braun Medical Inc.	fd191c06-9d3b-4e46-9f79-90f6af614947	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METRONIDAZOLE generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Northstar Rx LLC	65cda174-d840-488a-96d0-74d6086b7048	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	St. Mary's Medical Park Pharmacy	60689b96-cb58-925a-e053-2a91aa0a32a3	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Bryant Ranch Prepack	1277591d-ccf4-428a-b647-cb1ef3fbf561	2026-04-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	5cc3fd98-d579-432e-a4b5-b6d5586991a6	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	02046a22-a5eb-4bb7-bec7-e5a2aa55e142	2026-03-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	c225a455-ec25-2213-e053-2995a90a3389	2026-03-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	ca450fad-0513-4c45-8ea0-1f46bcbf6a36	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	BluePoint Laboratories	3cf021b6-5794-4a86-b09d-bece0ba8b302	2026-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Viona Pharmaceuticals Inc	40a8c59b-a46d-4e5b-bd38-330cdbc1022c	2026-02-19	Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Zydus Lifesciences Limited	aa7fc40e-64a1-4155-bb39-77ed7b7f2e67	2026-02-19		Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	b49a8ad0-2cf9-4386-8bf5-1b1df87b0022	2026-02-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	dc28753c-95ec-4b41-ad77-c4a66698d9db	2026-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
metronidazole vaginal	METRONIDAZOLE	REMEDYREPACK INC.	b8fbd105-90ae-4af4-9313-61834aaf4a2c	2026-02-13	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-7077	Metronidazole	Metronidazole	Sandoz Inc.	ANDA	Current
0781-7077	Metronidazole	Metronidazole	Sandoz Inc.	ANDA	Current
50090-1012	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
50090-1012	Metronidazole	Metronidazole	A-S Medication Solutions	ANDA	Current
53002-7340	Metronidazole	Metronidazole	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-7340	Metronidazole	Metronidazole	RPK Pharmaceuticals, Inc.	ANDA	Current
63629-8731	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
63629-8731	Metronidazole	Metronidazole	Bryant Ranch Prepack	ANDA	Current
68071-5009	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5009	Metronidazole	Metronidazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-0539	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0539	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0539	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0539	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-0539	Metronidazole	Metronidazole	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9026	ORIG	2006-11-06