Application 215794

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

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
A215794-001	METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB		2022-01-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A215794-001	AB

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.

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	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215794-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2022-01-27	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215794-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215794-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215794-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215794-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215794-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215794-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215794-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215794-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215794-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215794-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215794-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215794-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215794-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215794-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215794-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215794-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215794-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215794-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215794-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215794-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215794-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215794-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215794-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215794-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215794-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215794-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215794-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215794-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215794-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215794-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215794-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215794-001	AB	1	`a50c72e98297…`

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 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	Northstar Rx LLC	65cda174-d840-488a-96d0-74d6086b7048	2026-04-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215794 application number: ANDA215794 ndc (product): 16714-557
Metronidazole	METRONIDAZOLE	GLENMARK PHARMACEUTICALS INC., USA	6736c100-a7fe-44ea-8579-5537537ff9b8	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215794 application number: ANDA215794 ndc (product): 68462-184
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	e6ece591-38fa-4016-bd62-d31a3e5a8da3	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215794 application number: ANDA215794
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	9d41a8b3-b8cc-4fb6-9813-d3bfa048ed78	2024-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215794 application number: ANDA215794

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-557	Metronidazole	Metronidazole	Northstar Rx LLC	ANDA	Current
68462-184	Metronidazole	Metronidazole	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current
68462-184	Metronidazole	Metronidazole	GLENMARK PHARMACEUTICALS INC., USA	ANDA	Current