Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204836
Company: HETERO LABS LTD V

Products on ANDA 204836

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204836

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/02/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 204836

MOXIFLOXACIN HYDROCHLORIDE

TABLET;ORAL; EQ 400MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	202632	AUROBINDO PHARMA LTD
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	207285	CHARTWELL RX
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	205348	CROSSMEDIKA SA
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	076938	DR REDDYS
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	204836	HETERO LABS LTD V
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	208682	MSN
MOXIFLOXACIN HYDROCHLORIDE	MOXIFLOXACIN HYDROCHLORIDE	EQ 400MG BASE	TABLET;ORAL	Prescription	No	AB	077437	TEVA PHARMS USA