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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201971
Company: AUROBINDO PHARMA USA

Products on ANDA 201971

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	AB	No	No
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201971

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/15/2017	ORIG-1	Approval	Not Applicable		Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201971Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/201971Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/14/2021	SUPPL-5	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
01/02/2020	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 201971

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/15/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201971Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 201971

RASAGILINE MESYLATE

TABLET;ORAL; EQ 0.5MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZILECT	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	Yes	AB	021641	TEVA
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	201889	ALKEM LABS LTD
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	201971	AUROBINDO PHARMA USA
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	201942	CARNEGIE
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	201892	CHARTWELL RX
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	208866	MACLEODS PHARMS LTD
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	207004	MICRO LABS
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	201970	ORBION PHARMS
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	206153	REGCON HOLDINGS
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	218163	RISING
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	210150	TORRENT

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AZILECT	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	Yes	AB	021641	TEVA
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	201889	ALKEM LABS LTD
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	201971	AUROBINDO PHARMA USA
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	201942	CARNEGIE
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	201892	CHARTWELL RX
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	208866	MACLEODS PHARMS LTD
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	207004	MICRO LABS
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	201970	ORBION PHARMS
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	206153	REGCON HOLDINGS
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	218163	RISING
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	210150	TORRENT

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