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Details for New Drug Application (NDA): 075115

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NDA 075115 describes NITROGLYCERIN, which is a drug marketed by Abraxis Pharm, Kremers Urban Pharms, Intl Medication, Hospira, Smith And Nephew, Luitpold, Fougera Pharms Inc, Mylan Technologies, Hercon Pharm, Dr Reddys Labs Inc, Perrigo Israel, and Baxter Hlthcare, and is included in twenty-two NDAs. It is available from thirteen 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-eight suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the nitroglycerin profile page.

Summary for NDA: 075115

Kremers Urban Pharms
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075115

Physiological EffectVasodilation

Suppliers and Packaging for NDA: 075115

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FILM, EXTENDED RELEASE;TRANSDERMAL 075115 ANDA Kremers Urban Pharmaceuticals Inc. 62175-123 62175-123-01 30 FILM, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (62175-123-01)
FILM, EXTENDED RELEASE;TRANSDERMAL 075115 ANDA Kremers Urban Pharmaceuticals Inc. 62175-123 62175-123-11 100 FILM, EXTENDED RELEASE in 1 PACKAGE (62175-123-11)

Summary for product number 001

Approval Date:Aug 10, 2004TE:RLD:No

Summary for product number 002

Approval Date:Aug 10, 2004TE:RLD:No

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