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NDA

METOLAZONE | N019532 | CHARTWELL MOLECULAR HOLDINGS 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 Chain4 active DMFs6 inactive

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

SIEGFRIED EVIONNAZ SAMETOLAZONE

DMF 57481985

CENTAUR PHARMACEUTICALS PRIVATE LTDMETOLAZONE USP

DMF 303102016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMETOLAZONE USP

DMF 328682018

MSN LIFE SCIENCES PRIVATE LTDMETOLAZONE USP

DMF 336982019

EASTMAN KODAK COInactiveMETOLAZONE (ZAROXOLYN)

DMF 46551982

SUMIKA FINE CHEMICALS CO LTDInactiveMETOLAZONE

DMF 64381986

HEXAGON LABORATORIES INCInactiveMETOLAZONE

DMF 64871986

DIOSYNTH BVInactiveMETOLAZONE

DMF 75291988

HOECHST MARION ROUSSEL SAInactiveMETOLAZONE

DMF 84211990

XIAN LIBANG PHARMACEUTICAL CO LTDInactiveMETOLAZONE USP

DMF 160012002

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 25, 2003	SUPPL -16	View Letter (PDF)
Oct 29, 2002	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Oct 30, 1987

No patent or exclusivity listings for this strength.