Application 079033

Type: ANDA
Sponsor: MYLAN INSTITUTIONAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOMEPIZOLE	FOMEPIZOLE	INJECTABLE;INJECTION	1.5GM/1.5ML (1GM/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A079033-001	FOMEPIZOLE	FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION			2009-04-07

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A079033-001	FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	2009-04-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079033-001	FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	2009-04-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079033-001	FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	2009-04-07	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A079033-001	FOMEPIZOLE	1.5GM/1.5ML (1GM/ML)	INJECTABLE / INJECTION	2009-04-07	`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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fomepizole	FOMEPIZOLE	Zydus Pharmaceuticals USA Inc.	256910fe-91f2-48f6-b0b4-55edc52dacd4	2025-11-20	Adverse reactions	Name fallback brand name: Fomepizole generic name: FOMEPIZOLE
Fomepizole	FOMEPIZOLE	Navinta LLC	6fed6052-f159-46d6-8be1-31e18a7ba918	2024-12-19	Adverse reactions	Name fallback brand name: Fomepizole generic name: FOMEPIZOLE
Fomepizole	FOMEPIZOLE	Sagent Pharmaceuticals	1dea37fd-ec17-416e-b28e-980a87d49e1a	2023-10-26	Adverse reactions	Name fallback brand name: Fomepizole generic name: FOMEPIZOLE
Fomepizole	FOMEPIZOLE	Gland Pharma Limited	7e133194-dacb-446a-a657-2d2430a02373	2023-07-07	Adverse reactions	Name fallback brand name: Fomepizole generic name: FOMEPIZOLE
Fomepizole	FOMEPIZOLE	Mylan Institutional LLC	911312e2-3a7c-4c97-88a8-b8d92cd12923	2021-04-15	Adverse reactions	Name fallback brand name: Fomepizole generic name: FOMEPIZOLE
fomepizole	FOMEPIZOLE	American Regent, Inc.	a31d0148-2729-49de-b666-f24b0dfd2401	2020-02-11	Adverse reactions	Name fallback brand name: fomepizole generic name: FOMEPIZOLE
fomepizole	FOMEPIZOLE	American Regent, Inc.	82dc2920-af7f-4e43-9f6d-8877a71884cd	2019-12-06	Adverse reactions	Name fallback brand name: fomepizole generic name: FOMEPIZOLE

Reported adverse events (FAERS/openFDA)#

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