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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

NITROGLYCERIN

ANDANot in Orange Book

NITROGLYCERIN | A214565 | PADAGIS ISRAEL

API Supply Chain3 active DMFs4 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

SOCIETE SUISSE DES EXPLOSIFSInactiveNITROGLYCERIN,PENTAERYTHRITOL TETRANITRATE AND ISOSORBIDE DINITRATE

DMF 45041982

DYNAMIT NOBEL AGInactiveNITROGLYCERIN 5% IN MIGLYOL 829

DMF 68471987

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

Products (1)

#001 — 0.4%

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OINTMENT;INTRA-ANAL | Approved: Jul. 6, 2026

No patent or exclusivity listings for this strength.