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Drugs@FDA: FDA-Approved Drugs

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

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 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 201892 SANDOZ INC

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 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 201892 SANDOZ INC
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