Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076119
Company: TEVA
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
01/24/2003 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/76119tapd.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076119.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/24/2020 SUPPL-30 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/24/2020 SUPPL-27 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/24/2020 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

10/24/2014 SUPPL-24 Labeling-Medication Guide, 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.

01/31/2013 SUPPL-22 Labeling-Package Insert

Label is not available on this site.

07/19/2010 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/06/2007 SUPPL-14 Labeling

Label is not available on this site.

11/06/2007 SUPPL-13 Labeling

Label is not available on this site.

07/21/2006 SUPPL-12 Labeling

Label is not available on this site.

07/12/2005 SUPPL-6 Labeling

Label is not available on this site.

12/29/2004 SUPPL-4 Labeling

Label is not available on this site.

06/19/2003 SUPPL-2 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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