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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205798
Company: SQUARE PHARMS PLC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIRTAZAPINE MIRTAZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
MIRTAZAPINE MIRTAZAPINE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription AB No No
MIRTAZAPINE MIRTAZAPINE 45MG TABLET, ORALLY DISINTEGRATING;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
06/01/2017 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/06/2023 SUPPL-2 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.
10/16/2020 SUPPL-1 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

MIRTAZAPINE

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 077376 AUROBINDO PHARMA
MIRTAZAPINE MIRTAZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 205798 SQUARE PHARMS PLC
REMERON SOLTAB MIRTAZAPINE 15MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021208 ORGANON USA ORGANON

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 077376 AUROBINDO PHARMA
MIRTAZAPINE MIRTAZAPINE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 205798 SQUARE PHARMS PLC
REMERON SOLTAB MIRTAZAPINE 30MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021208 ORGANON USA ORGANON

TABLET, ORALLY DISINTEGRATING;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, ORALLY DISINTEGRATING;ORAL Prescription No AB 077376 AUROBINDO PHARMA
MIRTAZAPINE MIRTAZAPINE 45MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription No AB 205798 SQUARE PHARMS PLC
REMERON SOLTAB MIRTAZAPINE 45MG TABLET, ORALLY DISINTEGRATING;ORAL Prescription Yes AB 021208 ORGANON USA ORGANON
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