Application 208162

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METRONIDAZOLE	METRONIDAZOLE	TABLET;ORAL	250MG	No	No
002	METRONIDAZOLE	METRONIDAZOLE	TABLET;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208162-001	METRONIDAZOLE	METRONIDAZOLE	250MG	TABLET / ORAL	AB		2016-05-25
A208162-002	METRONIDAZOLE	METRONIDAZOLE	500MG	TABLET / ORAL	AB		2016-05-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A208162-001	AB
A208162-002	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 3 · 86 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
2026-09-14 22:38:34	2026-08	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208162-001	METRONIDAZOLE	250MG	TABLET / ORAL	AB	2016-05-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208162-002	METRONIDAZOLE	500MG	TABLET / ORAL	AB	2016-05-25	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208162-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208162-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208162-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208162-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208162-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208162-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208162-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208162-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208162-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208162-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208162-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208162-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208162-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208162-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208162-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208162-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208162-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208162-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208162-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208162-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208162-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208162-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208162-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208162-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208162-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208162-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208162-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208162-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208162-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208162-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208162-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208162-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208162-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208162-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208162-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208162-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208162-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208162-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208162-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208162-002	AB	1	`74a2ff9319b5…`

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 3 of 8 · 147 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	Name fallback generic name: METRONIDAZOLE
metronidazole vaginal	METRONIDAZOLE	REMEDYREPACK INC.	b07f42dd-75d4-499a-984f-c06894ff3a45	2026-02-12	Warnings, Adverse reactions	Name fallback generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Sportpharm LLC	dc8e448e-ac4e-4efc-8851-c368e31b9d69	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Fougera Pharmaceuticals, LLC	43ed872b-63ac-4a22-9c9e-cc0e05bcc41e	2026-01-28	Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Fougera Pharmaceuticals, LLC	5368755a-dd37-4e34-843f-ece6bac8ef6a	2026-01-28	Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	1a28dce0-07af-401a-a6ac-1c2ee559c668	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Preferred Pharmaceuticals Inc.	ab695a3e-1721-491a-97a2-c3f617a8d9fc	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	GLENMARK PHARMACEUTICALS INC., USA	6736c100-a7fe-44ea-8579-5537537ff9b8	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
METRONIDAZOLE	METRONIDAZOLE	Direct_Rx	90a5acb3-f8cc-1e82-e053-2995a90a4e97	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METRONIDAZOLE generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	American Health Packaging	c90da73c-e48e-411a-bd75-0b107f1141cc	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Solaris Pharma Corporation	94a83daa-6e34-419d-849a-6f18d3b8c586	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	06bd4afb-4a45-294c-e063-6394a90a7ab1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	f2f55405-7f21-3ccc-e053-2a95a90a195a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Northwind Health Company, LLC	f7e5dacd-0bc4-4ac4-e053-6394a90a457a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Proficient Rx LP	a56c2842-8ad4-4396-8eb6-cbcd1629fcb1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Redpharm Drug	300b51d0-8fca-24ef-e063-6294a90ad2b9	2025-12-23	Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Redpharm Drug	32523df9-8c47-200f-e063-6294a90ac890	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Chartwell RX, LLC	40509b3c-b725-400c-abe5-d6d5714d405d	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	60ad086d-6f54-4134-b608-53a6ff571ff8	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	A-S Medication Solutions	2a5af710-dbf7-41c1-9b3a-35e69b3fa4ab	2025-12-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole 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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64380-779	Metronidazole	Metronidazole	Strides Pharma Science Limited	ANDA	Current
64380-779	Metronidazole	Metronidazole	Strides Pharma Science Limited	ANDA	Current
64380-779	Metronidazole	Metronidazole	Strides Shasun Limited	ANDA	Current
64380-779	Metronidazole	Metronidazole	Strides Pharma Science Limited	ANDA	Current
64380-780	Metronidazole	Metronidazole	Strides Pharma Science Limited	ANDA	Current
64380-780	Metronidazole	Metronidazole	Strides Pharma Science Limited	ANDA	Current
64380-780	Metronidazole	Metronidazole	Strides Shasun Limited	ANDA	Current
64380-780	Metronidazole	Metronidazole	Strides Pharma Science Limited	ANDA	Current