Viewing data from:

SULFAMYLON

NDA

MAFENIDE ACETATE | N019832 | MYLAN INSTITUTIONAL INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs

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

MATRIX PHARMACORP PRIVATE LTDMAFENIDE ACETATE USP

DMF 246152011

PH HEALTH LTDMAFENIDE ACETATE USP

DMF 247222011

MATRIX PHARMACORP PRIVATE LTDMAFENIDE ACETATE USP

DMF 322922017

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#003 — 5%

RLD

0 patents0 exclusivities▴

FOR SOLUTION;TOPICAL | Approved: Jun 5, 1998

No patent or exclusivity listings for this strength.