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NEPTAZANE

NDA

METHAZOLAMIDE | N011721 | LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO

2 strengths0 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 DMFs3 inactive

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

FINE CHEMICALS CORP PTY LTDMETHAZOLAMIDE

DMF 79821989

DELMAR CHEMICALS INCMETHAZOLAMIDE

DMF 86761990

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMETHAZOLAMIDE

DMF 323342017

MICRO LABS LTDMETHAZOLAMIDE USP

DMF 325142018

CHEMISCHE FABRIK WEYL GMBHInactiveMETHAZOLAMIDE

DMF 78561989

TCI AMERICAInactiveMETHAZOLAMIDE

DMF 78991989

CHONGQING NO. 5 PHARM. FACTORYInactiveMETHAZOLAMIDE

DMF 99351992

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

Products (2)

Sort:

#001 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 25, 1991