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Generated: January 23, 2019

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Details for New Drug Application (NDA): 021359

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NDA 021359 describes RECTIV, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from two suppliers. Additional details are available on the RECTIV profile page.

The generic ingredient in RECTIV is nitroglycerin. There are thirty-six drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 021359
Applicant:Allergan Sales Llc
Formulation / Manufacturing:see details
Pharmacology for NDA: 021359
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 021359
Suppliers and Packaging for NDA: 021359
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RECTIV nitroglycerin OINTMENT;INTRA-ANAL 021359 NDA ProStrakan, Inc. 42747-235 42747-235-30 1 TUBE in 1 CARTON (42747-235-30) > 30 g in 1 TUBE
RECTIV nitroglycerin OINTMENT;INTRA-ANAL 021359 NDA Allergan, Inc. 58914-301 58914-301-80 1 TUBE in 1 CARTON (58914-301-80) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;INTRA-ANALStrength0.4%
Approval Date:Jun 21, 2011TE:RLD:Yes

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