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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076122
Company: MYLAN
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
06/19/2003 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76122tapd.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076122.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/15/2022 SUPPL-29 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/04/2020 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/04/2020 SUPPL-26 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

11/22/2019 SUPPL-25 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/22/2019 SUPPL-24 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

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

Label is not available on this site.

08/27/2015 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

03/18/2014 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

06/28/2011 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

11/06/2007 SUPPL-10 Labeling

Label is not available on this site.

11/06/2007 SUPPL-9 Labeling

Label is not available on this site.

09/26/2005 SUPPL-2 Labeling

Label is not available on this site.

12/29/2004 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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