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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207004
Company: MICRO LABS

Products on ANDA 207004

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 207004

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/29/2019	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
10/16/2020	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 207004

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	201892	CHARTWELL RX
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 0.5MG BASE	TABLET;ORAL	Prescription	No	AB	206153	INDOCO
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	218163	SKG PHARMA

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	201892	CHARTWELL RX
RASAGILINE MESYLATE	RASAGILINE MESYLATE	EQ 1MG BASE	TABLET;ORAL	Prescription	No	AB	206153	INDOCO
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	218163	SKG PHARMA

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