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PROGLYCEM

NDA

DIAZOXIDE | N017453 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from LyphoMed, Inc. FDA-1987-P-0374 LyphoMed, Inc. filed this citizen petition under section 505 of the Federal Food, Drug, and Cosmetic Act requesting that the Commissioner of Food and Drugs declare Diazoxide Injection USP 15 mg/mL (150 mg/10 mL) in a single-dose syringe suitable for evaluation as an abbreviated new drug application.	Other	2017-07-26	Granted	LyphoMed

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs1 inactive

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

LUNDBECK PHARMACEUTICALS ITALY SPADIAZOXIDE

DMF 70311987

NOVITIUM PHARMA LLCDIAZOXIDE USP

DMF 312492017

BIOPHORE INDIA PHARMACEUTICALS PVT LTDDIAZOXIDE

DMF 323352017

GUANG'AN KINGDAY PHARMA AND CHEM CO LTDDIAZOXIDE USP

DMF 327712018

MSN LABORATORIES PRIVATE LTDDIAZOXIDE USP

DMF 353512020

SUZHOU YIFAN PHARMACEUTICAL CO LTDDIAZOXIDE

DMF 428902025

TRANSO PHARM PRODUKTIONS GMBHInactiveDIAZOXIDE

DMF 168192003

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

Approval Letters

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/ML

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.