Viewing data from:

NITROSTAT

NDA

NITROGLYCERIN | N021134 | VIATRIS SPECIALTY LLC

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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

7 letters from Drugs@FDA

Date	Submission	Document
Jan 26, 2018	SUPPL -10	View Letter (PDF)
Jan 31, 2017	SUPPL -9	View Letter (PDF)
Aug 29, 2016	SUPPL -8	View Letter (PDF)
Mar 10, 2014	SUPPL -7	View Letter (PDF)
Jul 25, 2011	SUPPL -5	View Letter (PDF)
Jul 21, 2010	SUPPL -4	View Letter (PDF)
May 1, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.3MG

RLDAB

0 patents0 exclusivities▴

TABLET;SUBLINGUAL | Approved: May 1, 2000

No patent or exclusivity listings for this strength.

#002 — 0.4MG

RLDAB

0 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: May 1, 2000

#003 — 0.6MG

RLDAB

0 patents0 exclusivities▾

TABLET;SUBLINGUAL | Approved: May 1, 2000