Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076241
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIRTAZAPINE MIRTAZAPINE 15MG TABLET;ORAL Discontinued None No No
MIRTAZAPINE MIRTAZAPINE 30MG TABLET;ORAL Discontinued None No No
MIRTAZAPINE MIRTAZAPINE 45MG TABLET;ORAL Discontinued None 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
06/25/2003 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/076241.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/11/2008 SUPPL-12 Labeling

Label is not available on this site.

10/30/2007 SUPPL-9 Labeling

Label is not available on this site.

03/23/2007 SUPPL-7 Labeling

Label is not available on this site.

07/21/2006 SUPPL-6 Labeling

Label is not available on this site.

07/12/2005 SUPPL-5 Labeling

Label is not available on this site.

12/29/2004 SUPPL-3 Labeling

Label is not available on this site.

10/22/2003 SUPPL-1 Labeling

Label is not available on this site.

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