Application 079084

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GATIFLOXACIN	GATIFLOXACIN	SOLUTION/DROPS;OPHTHALMIC	0.3%	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
A079084-001	GATIFLOXACIN	GATIFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC			2011-08-19

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A079084-001	GATIFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	2011-08-19	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079084-001	GATIFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	2011-08-19	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A079084-001	GATIFLOXACIN	0.3%	SOLUTION/DROPS / OPHTHALMIC	2011-08-19	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GATIFLOXACIN	GATIFLOXACIN	Leading Pharma, LLC	826cf8c4-4be5-4614-bd42-47c1d0c9df58	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: GATIFLOXACIN generic name: GATIFLOXACIN
Gatifloxacin	GATIFLOXACIN	Sandoz Inc	9e6fcd14-1fee-493f-811c-e18cbfbee65b	2025-02-15	Warnings, Adverse reactions	Name fallback brand name: Gatifloxacin generic name: GATIFLOXACIN
ZYMAXID	GATIFLOXACIN	Allergan, Inc.	1160b16c-929a-4e85-9c0b-1d8c96a7678b	2016-09-08	Warnings, Adverse reactions	Name fallback generic name: GATIFLOXACIN

Reported adverse events (FAERS/openFDA)#

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