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Details for New Drug Application (NDA): 089885

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NDA 089885 describes NITROGLYCERIN, which is a drug marketed by Abraxis Pharm, Kremers Urban Pharms, Intl Medication, Hospira, Smith And Nephew, Luitpold, Fougera, Mylan Technologies, Hercon Pharm, Dr Reddys Labs Inc, Perrigo Israel, and Baxter Hlthcare, and is included in twenty-two NDAs. It is available from eleven 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-six 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: 089885

Hercon Pharm
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 089885

Physiological EffectVasodilation

Suppliers and Packaging for NDA: 089885

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FILM, EXTENDED RELEASE;TRANSDERMAL 089885 ANDA Harvard Drug Group, LLC 0904-5496 0904-5496-46 30 POUCH in 1 CARTON (0904-5496-46) > 1 PATCH in 1 POUCH > 24 h in 1 PATCH
FILM, EXTENDED RELEASE;TRANSDERMAL 089885 ANDA Hercon Laboratories Corporation 49730-112 49730-112-30 30 POUCH in 1 BOX (49730-112-30) > 1 PATCH in 1 POUCH > 24 h in 1 PATCH

Summary for product number 001

Approval Date:Oct 30, 1998TE:AB2RLD:No

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