Viewing data from:

PAROXETINE MESYLATE

ANDA

PAROXETINE MESYLATE | A207188 | PRINSTON PHARMACEUTICAL INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: BRISDELLE(TE code: AB)

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDPAROXETINE MESYLATE

DMF 280912014

WANBURY LTDPAROXETINE MESYLATE

DMF 305732016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 7, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 7.5MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 18, 2017

No patent or exclusivity listings for this strength.