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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205348
Company: CROSSMEDIKA SA

Products on ANDA 205348

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 205348

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/14/2016	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/07/2020	SUPPL-4	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/07/2020	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/07/2020	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205348

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

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