Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076307
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIRTAZAPINE MIRTAZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
MIRTAZAPINE MIRTAZAPINE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Discontinued None No No
MIRTAZAPINE MIRTAZAPINE 45MG TABLET, ORALLY DISINTEGRATING;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
12/17/2003 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
02/25/2020 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

02/25/2020 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/07/2007 SUPPL-14 Labeling

Label is not available on this site.

11/07/2007 SUPPL-11 Labeling

Label is not available on this site.

07/14/2005 SUPPL-8 Labeling

Label is not available on this site.

02/28/2006 SUPPL-7 Manufacturing (CMC)-New Strength

Label is not available on this site.

02/28/2006 SUPPL-6 Labeling

Label is not available on this site.

02/28/2006 SUPPL-5 Manufacturing (CMC)-New Strength

Label is not available on this site.

11/23/2004 SUPPL-4 Labeling

Label is not available on this site.

02/28/2006 SUPPL-2 Labeling

Label is not available on this site.

02/28/2006 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

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