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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077666
Company: APOTEX INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
08/22/2007 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
01/07/2021 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

11/22/2019 SUPPL-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/22/2019 SUPPL-11 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/22/2019 SUPPL-10 Labeling-Medication Guide, Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

12/03/2015 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/29/2013 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

08/29/2013 SUPPL-6 Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

06/28/2011 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

06/22/2009 SUPPL-3 Labeling

Label is not available on this site.

11/06/2007 SUPPL-1 Labeling

Label is not available on this site.

MIRTAZAPINE

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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