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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202632
Company: AUROBINDO PHARMA LTD

Products on ANDA 202632

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 202632

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/2014	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202632Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2019	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
12/05/2019	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/05/2019	SUPPL-10	Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/05/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
12/05/2019	SUPPL-6	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/05/2019	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/05/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
03/20/2015	SUPPL-1	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202632

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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