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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 072034


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NDA 072034 describes NITROGLYCERIN, which is a drug marketed by Lannett Co Inc, Mylan Technologies, Zydus Pharms, Abraxis Pharm, Am Regent, Hospira, Intl Medication, Luitpold, Smith And Nephew, Cosette, Fougera Pharms Inc, Padagis Israel, Actavis Labs Fl Inc, Aurobindo Pharma, Dr Reddys, Glenmark Speclt, Mankind Pharma, Natco, Rubicon, Sigmapharm Labs Llc, and Baxter Hlthcare, and is included in thirty-one NDAs. It is available from twenty-four suppliers. Additional details are available on the NITROGLYCERIN profile page.

The generic ingredient in NITROGLYCERIN is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 072034
Tradename:NITROGLYCERIN
Applicant:Am Regent
Ingredient:nitroglycerin
Patents:0
Pharmacology for NDA: 072034
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 072034
Suppliers and Packaging for NDA: 072034
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROGLYCERIN nitroglycerin INJECTABLE;INJECTION 072034 ANDA Henry Schein, Inc. 0404-9928 0404-9928-10 1 VIAL in 1 BAG (0404-9928-10) / 10 mL in 1 VIAL
NITROGLYCERIN nitroglycerin INJECTABLE;INJECTION 072034 ANDA American Regent, Inc. 0517-4810 0517-4810-25 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-4810-25) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-4810-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:May 24, 1988TE:RLD:No

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