Application 211786

Type: ANDA
Sponsor: PERRIGO UK FINCO

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 42.

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
A211786-001	METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB		2019-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211786-001	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.

Product history page 1 of 2 · 42 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
2026-08-18 06:07:40	2026-07	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211786-001	METRONIDAZOLE	0.75%	GEL / VAGINAL	AB	2019-07-02	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211786-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211786-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211786-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211786-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211786-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211786-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211786-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211786-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211786-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211786-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211786-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211786-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211786-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211786-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211786-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211786-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211786-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211786-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211786-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211786-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211786-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211786-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211786-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211786-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211786-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211786-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211786-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211786-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211786-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211786-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211786-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211786-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211786-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211786-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211786-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211786-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211786-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211786-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211786-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211786-001	AB	1	`e64feba35796…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
metronidazole vaginal	METRONIDAZOLE	REMEDYREPACK INC.	b8fbd105-90ae-4af4-9313-61834aaf4a2c	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211786 application number: ANDA211786 ndc (product): 70518-2814
metronidazole vaginal	METRONIDAZOLE	A-S Medication Solutions	58ce793b-9b6a-4cd7-94ae-215dbf9e2ef7	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211786 application number: ANDA211786 ndc (product): 50090-4809
metronidazole vaginal	METRONIDAZOLE	Padagis Israel Pharmaceuticals Ltd	eb240e7b-cec8-497b-8a49-7ed768e2b431	2023-07-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211786 application number: ANDA211786 ndc (product): 45802-139

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45802-139	metronidazole vaginal	metronidazole	Perrigo New York Inc	ANDA	Current
45802-139	metronidazole vaginal	metronidazole	Padagis Israel Pharmaceuticals Ltd	ANDA	Current
50090-4809	metronidazole vaginal	metronidazole	A-S Medication Solutions	ANDA	Current
63629-8680	metronidazole vaginal	metronidazole	Bryant Ranch Prepack	ANDA	Current
63629-8680	metronidazole vaginal	metronidazole	Bryant Ranch Prepack	ANDA	Current
63629-8680	metronidazole vaginal	metronidazole	Bryant Ranch Prepack	ANDA	Current
63629-8680	metronidazole vaginal	metronidazole	Bryant Ranch Prepack	ANDA	Current
70518-2814	metronidazole vaginal	metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-2814	metronidazole vaginal	metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-2814	metronidazole vaginal	metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-2814	metronidazole vaginal	metronidazole	REMEDYREPACK INC.	ANDA	Current
70518-2814	metronidazole vaginal	metronidazole	REMEDYREPACK INC.	ANDA	Current