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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201970
Company: ORBION PHARMS

Products on ANDA 201970

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 201970

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/15/2016	ORIG-1	Approval	Not Applicable			Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/16/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
01/02/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
01/02/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201970

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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