Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207188
Company: PRINSTON 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
08/18/2017 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207188Orig1s000ltr.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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