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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207139
Company: ACTAVIS LABS FL INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PAROXETINE MESYLATE PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE;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
06/20/2017 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207139Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207139Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/20/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207139Orig1s000lbl.pdf

PAROXETINE MESYLATE

CAPSULE;ORAL; EQ 7.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BRISDELLE PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE;ORAL Prescription Yes AB 204516 SEBELA IRELAND LTD
PAROXETINE MESYLATE PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE;ORAL Prescription No AB 207139 ACTAVIS LABS FL INC
PAROXETINE MESYLATE PAROXETINE MESYLATE EQ 7.5MG BASE CAPSULE;ORAL Prescription No AB 207188 PRINSTON INC
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