Application 076462

Type: ANDA
Sponsor: ABLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METRONIDAZOLE	METRONIDAZOLE	TABLET, EXTENDED RELEASE;ORAL	750MG	No	No

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
A076462-001	METRONIDAZOLE	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL			2003-06-25

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076462-001	METRONIDAZOLE	750MG	TABLET, EXTENDED RELEASE / ORAL	2003-06-25	`f41ea6bd6efb…`

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 · 148 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	49bed450-7fa8-401c-8c8c-afc1c61d473a	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	REMEDYREPACK INC.	3c0ebb00-a0ae-4f64-9bfc-de01193191e8	2026-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Coupler LLC	545f2900-745c-c33c-e063-6294a90a5e4f	2026-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
Metronidazole	METRONIDAZOLE	Cardinal Health 107, LLC	4e1ac737-c353-4764-bd35-dc844e75b562	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Metronidazole generic name: METRONIDAZOLE
METRONIDAZOLE	METRONIDAZOLE	Sun Pharmaceutical Industries, Inc.	7187779a-1f4c-4607-af53-4119e324aad5	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: METRONIDAZOLE generic name: METRONIDAZOLE
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	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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.