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Generated: May 20, 2019

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Details for New Drug Application (NDA): 019790

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NDA 019790 describes DILATRATE-SR, which is a drug marketed by Auxilium Pharms Llc and is included in one NDA. It is available from one supplier. Additional details are available on the DILATRATE-SR profile page.

The generic ingredient in DILATRATE-SR is isosorbide dinitrate. There are thirty-seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the isosorbide dinitrate profile page.
Summary for 019790
Applicant:Auxilium Pharms Llc
Ingredient:isosorbide dinitrate
Formulation / Manufacturing:see details
Pharmacology for NDA: 019790
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 019790
Suppliers and Packaging for NDA: 019790
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DILATRATE-SR isosorbide dinitrate CAPSULE, EXTENDED RELEASE;ORAL 019790 NDA Endo Pharmaceuticals, Inc. 52244-920 52244-920-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (52244-920-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Sep 2, 1988TE:RLD:Yes

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