Application 078073

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	SOLUTION; OPHTHALMIC	0.5%	No	No

Source provenance: Browse the complete Orange Book source catalog.

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 2 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Moxifloxacin	MOXIFLOXACIN HYDROCHLORIDE	Fresenius Kabi USA, LLC	a4e28b09-714b-46e7-b4e6-0163cad78fc5	2024-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	A-S Medication Solutions	c71e5987-edd7-4c38-b646-3e48a6e51bf4	2023-11-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Moxifloxacin Hydrochloride generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Hydrochloride	MOXIFLOXACIN HYDROCHLORIDE	Upsher-Smith Laboratories, LLC	5a5d72e2-aa39-4ead-af72-d3cabe72a5b7	2023-05-30	Warnings, Adverse reactions	Name fallback brand name: Moxifloxacin Hydrochloride generic name: MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin Ophthalmic Solution	MOXIFLOXACIN HYDROCHLORIDE	Sandoz Inc	fc88791b-24da-48a4-85f5-93a8af3d0b51	2020-06-15	Warnings, Adverse reactions	Name fallback generic name: MOXIFLOXACIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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