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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090080
Company: APOTEX

Products on ANDA 090080

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090080

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2017	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/14/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090080

MOXIFLOXACIN HYDROCHLORIDE

SOLUTION/DROPS;OPHTHALMIC; EQ 0.5% BASE
TE Code = AT1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	209469	ALEMBIC
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	090080	APOTEX
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	206242	EUGIA PHARMA
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	208778	GLAND
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	202867	LUPIN
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	217988	MANKIND PHARMA
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	202525	REGCON HOLDINGS
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	209698	SOMERSET THERAPS LLC
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	212616	UPSHER SMITH LABS
VIGAMOX	MOXIFLOXACIN HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT1	021598	HARROW EYE

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