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NITROGLYCERIN IN DEXTROSE 5%

NDA

NITROGLYCERIN | N019970 | BAXTER HEALTHCARE CORP

3 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 Chain3 active DMFs3 inactive

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

DYNAMIT NOBEL GMBH EXPLOSIVSTOFF UND SYSTEMTECHNIKNITROGLYCERIN

DMF 85241990

COPPERHEAD INVESTMENTS INCNITROGLYCERIN

DMF 115951995

BHARAT PHARMA (A UNIT OF BHARAT EXPLOSIVES LTD)NITROGLYCERIN AS IN DILUTED NITROGLYCERIN, USP

DMF 224352009

VICTOR M HERMELIN CO DIV K-V PHARMACAL COInactiveNITROGLYCERIN

DMF 9781966

ELI LILLY AND COInactiveNITROGLYCERIN AMPOULES

DMF 19231972

DYNAMIT NOBEL AGInactiveNITROGLYCERIN 5% IN MIGLYOL 829

DMF 68471987

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 22, 2016	SUPPL -18	View Letter (PDF)
Oct 3, 2014	SUPPL -15	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 10MG/100ML

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 29, 1989

No patent or exclusivity listings for this strength.

#002 — 20MG/100ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 29, 1989

#003 — 40MG/100ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Dec 29, 1989