Viewing data from:

IBUPROFEN LYSINE

ANDA

IBUPROFEN LYSINE | A202402 | XGEN PHARMACEUTICALS DJB INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: NEOPROFEN(TE code: AP)

API Supply Chain2 active DMFs

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

SOLARA ACTIVE PHARMA SCIENCES LTDIBUPROFEN LYSINE

DMF 369912022

SMS PHARMACEUTICALS LIMITEDIBUPROFEN LYSINE

DMF 411752025

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 1, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 20MG BASE/2ML (EQ 10MG BASE/ML)

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS | Approved: Mar 30, 2016

No patent or exclusivity listings for this strength.