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NDA

METHENAMINE HIPPURATE | N016151 | QUAGEN PHARMACEUTICALS LLC

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 Chain7 active DMFs5 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED EVIONNAZ SAMETHENAMINE HIPPURATE

DMF 73331988

APITORIA PHARMA PRIVATE LTDMETHENAMINE HIPPURATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 270212013

CHEMISCHE FABRIK BERG GMBHMETHENAMINE HIPPURATE

DMF 281202014

MICRO LABS LTDMETHENAMINE HIPPURATE USP

DMF 319882017

KREATIVE ORGANICS PRIVATE LTDMETHENAMINE HIPPURATE USP

DMF 346802020

SS PHARMA LLCMETHENAMINE HIPPURATE

DMF 400572024

KALINTIS HEALTHCARE PVT LTDMETHENAMINE HIPPURATE USP

DMF 403672025

JT BAKER CHEMICAL COInactiveMETHENAMINE HIPPURATE

DMF 49491983

JAME FINE CHEMICALS INCInactiveMETHENAMINE HIPPURATE

DMF 50181983

3M PHARMACEUTICALSInactiveMETHENAMINE HIPPURATE

DMF 71001987

CHEMISCHE FABRIK BERG GMBHInactiveMETHENAMINE HIPPURATE

DMF 75231988

SAI LIFE SCIENCES LTDInactiveMETHENAMINE HIPPURATE USP

DMF 290582015

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 13, 2008	SUPPL -25	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1GM

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.