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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-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: 208424

Tradename:
GONITRO
Applicant:
Pohl Boskamp
Ingredient:
nitroglycerin
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 208424

Ingredient-typeNitrates
Physiological EffectVasodilation

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 Espero Pharmaceuticals, Inc. 70007-400 70007-400-12 12 PACKET in 1 BOX (70007-400-12) > .0004 g in 1 PACKET (70007-400-01)
GONITRO
nitroglycerin
POWDER;SUBLINGUAL 208424 NDA Espero Pharmaceuticals, Inc. 70007-400 70007-400-36 36 PACKET in 1 BOX (70007-400-36) > .0004 g in 1 PACKET

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;SUBLINGUALStrength0.4MG/PACKET
Approval Date:Jun 8, 2016TE:RLD:Yes
Patent:9,101,592Patent Expiration:Mar 11, 2032Product Flag?YSubstance Flag?Delist Request?


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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