Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077376
Company: AUROBINDO PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIRTAZAPINE MIRTAZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
MIRTAZAPINE MIRTAZAPINE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
MIRTAZAPINE MIRTAZAPINE 45MG TABLET, ORALLY DISINTEGRATING;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
02/28/2006 ORIG-2 Approval Labeling

Label is not available on this site.

12/08/2005 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/16/2021 SUPPL-25 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/16/2021 SUPPL-23 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/15/2019 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

11/15/2019 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

11/15/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

01/16/2015 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

04/19/2013 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

04/19/2013 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

06/28/2011 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

10/30/2007 SUPPL-5 Labeling

Label is not available on this site.

10/30/2007 SUPPL-4 Labeling

Label is not available on this site.

02/28/2006 SUPPL-2 Labeling

Label is not available on this site.

02/28/2006 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

MIRTAZAPINE

TABLET, ORALLY DISINTEGRATING;ORAL; 15MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRTAZAPINE MIRTAZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077376 AUROBINDO PHARMA LTD
MIRTAZAPINE MIRTAZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 205798 ZYDUS PHARMS
REMERON SOLTAB MIRTAZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021208 ORGANON USA INC

TABLET, ORALLY DISINTEGRATING;ORAL; 30MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRTAZAPINE MIRTAZAPINE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077376 AUROBINDO PHARMA LTD
MIRTAZAPINE MIRTAZAPINE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 205798 ZYDUS PHARMS
REMERON SOLTAB MIRTAZAPINE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021208 ORGANON USA INC

TABLET, ORALLY DISINTEGRATING;ORAL; 45MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRTAZAPINE MIRTAZAPINE 45MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 077376 AUROBINDO PHARMA LTD
MIRTAZAPINE MIRTAZAPINE 45MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 205798 ZYDUS PHARMS
REMERON SOLTAB MIRTAZAPINE 45MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021208 ORGANON USA INC

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