Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076921
Company: AUROBINDO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIRTAZAPINE MIRTAZAPINE 7.5MG TABLET;ORAL Prescription AB No No
MIRTAZAPINE MIRTAZAPINE 15MG TABLET;ORAL Prescription AB No No
MIRTAZAPINE MIRTAZAPINE 30MG TABLET;ORAL Prescription AB No No
MIRTAZAPINE MIRTAZAPINE 45MG 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
10/22/2004 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
11/22/2019 SUPPL-35 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/22/2019 SUPPL-30 Labeling-Package Insert

Label is not available on this site.

11/22/2019 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

01/16/2015 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

01/31/2013 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

01/31/2013 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

12/30/2010 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

06/06/2011 SUPPL-15 Labeling

Label is not available on this site.

11/26/2007 SUPPL-11 Labeling

Label is not available on this site.

11/26/2007 SUPPL-10 Labeling

Label is not available on this site.

08/21/2007 SUPPL-8 Labeling

Label is not available on this site.

01/16/2007 SUPPL-5 Labeling

Label is not available on this site.

04/09/2007 SUPPL-4 Labeling

Label is not available on this site.

07/21/2006 SUPPL-2 Labeling

Label is not available on this site.

12/28/2005 SUPPL-1 Labeling

Label is not available on this site.

MIRTAZAPINE

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIRTAZAPINE MIRTAZAPINE 7.5MG TABLET;ORAL Prescription No AB 076921 AUROBINDO
MIRTAZAPINE MIRTAZAPINE 7.5MG TABLET;ORAL Prescription No AB 076541 SUN PHARM INDS INC

TABLET;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;ORAL Prescription No AB 077666 APOTEX INC
MIRTAZAPINE MIRTAZAPINE 15MG TABLET;ORAL Prescription No AB 076921 AUROBINDO
MIRTAZAPINE MIRTAZAPINE 15MG TABLET;ORAL Prescription No AB 076122 MYLAN
MIRTAZAPINE MIRTAZAPINE 15MG TABLET;ORAL Prescription No AB 076541 SUN PHARM INDS INC
MIRTAZAPINE MIRTAZAPINE 15MG TABLET;ORAL Prescription No AB 076119 TEVA
MIRTAZAPINE MIRTAZAPINE 15MG TABLET;ORAL Prescription No AB 076219 UPSHER SMITH LABS
REMERON MIRTAZAPINE 15MG TABLET;ORAL Prescription Yes AB 020415 ORGANON USA INC

TABLET;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;ORAL Prescription No AB 077666 APOTEX INC
MIRTAZAPINE MIRTAZAPINE 30MG TABLET;ORAL Prescription No AB 076921 AUROBINDO
MIRTAZAPINE MIRTAZAPINE 30MG TABLET;ORAL Prescription No AB 076122 MYLAN
MIRTAZAPINE MIRTAZAPINE 30MG TABLET;ORAL Prescription No AB 076541 SUN PHARM INDS INC
MIRTAZAPINE MIRTAZAPINE 30MG TABLET;ORAL Prescription No AB 076119 TEVA
MIRTAZAPINE MIRTAZAPINE 30MG TABLET;ORAL Prescription No AB 076219 UPSHER SMITH LABS
REMERON MIRTAZAPINE 30MG TABLET;ORAL Prescription Yes AB 020415 ORGANON USA INC

TABLET;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;ORAL Prescription No AB 077666 APOTEX INC
MIRTAZAPINE MIRTAZAPINE 45MG TABLET;ORAL Prescription No AB 076921 AUROBINDO
MIRTAZAPINE MIRTAZAPINE 45MG TABLET;ORAL Prescription No AB 076122 MYLAN
MIRTAZAPINE MIRTAZAPINE 45MG TABLET;ORAL Prescription No AB 076541 SUN PHARM INDS INC
MIRTAZAPINE MIRTAZAPINE 45MG TABLET;ORAL Prescription No AB 076119 TEVA
MIRTAZAPINE MIRTAZAPINE 45MG TABLET;ORAL Prescription No AB 076219 UPSHER SMITH LABS

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