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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 208424

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NDA 208424 describes GONITRO, which is a drug marketed by Pohl Boskamp and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the GONITRO profile page.

The generic ingredient in GONITRO is nitroglycerin. There are thirty-six drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the nitroglycerin profile page.
Summary for 208424
Applicant:Pohl Boskamp
Formulation / Manufacturing:see details
Pharmacology for NDA: 208424
Physiological EffectVasodilation
Medical Subject Heading (MeSH) Categories for 208424
Suppliers and Packaging for NDA: 208424
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GONITRO nitroglycerin POWDER;SUBLINGUAL 208424 NDA Allegis Pharmaceuticals, Inc. 28595-705 28595-705-12 12 PACKET in 1 BOX (28595-705-12) > 1 POWDER in 1 PACKET (28595-705-01)
GONITRO nitroglycerin POWDER;SUBLINGUAL 208424 NDA Allegis Pharmaceuticals, Inc. 28595-705 28595-705-36 36 PACKET in 1 BOX (28595-705-36) > 1 POWDER in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBLINGUALStrength0.4MG/PACKET
Approval Date:Jun 8, 2016TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Mar 11, 2032Product Flag?YSubstance Flag?Delist Request?

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Harvard Business School
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