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Details for New Drug Application (NDA): 018705

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NDA 018705 describes NITROLINGUAL PUMPSPRAY, which is a drug marketed by Pohl Boskamp and is included in one NDA. It is available from four suppliers. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the NITROLINGUAL PUMPSPRAY profile page.

The generic ingredient in NITROLINGUAL PUMPSPRAY 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: 018705

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

Pharmacology for NDA: 018705

Ingredient-typeNitrates
Physiological EffectVasodilation

Suppliers and Packaging for NDA: 018705

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROLINGUAL
nitroglycerin
AEROSOL;SUBLINGUAL 018705 NDA Arbor Pharmaceuticals, Inc. 24338-300 24338-300-20 1 BOTTLE in 1 CARTON (24338-300-20) > 200 SPRAY, METERED in 1 BOTTLE
NITROLINGUAL
nitroglycerin
AEROSOL;SUBLINGUAL 018705 NDA Arbor Pharmaceuticals, Inc. 24338-300 24338-300-65 1 BOTTLE in 1 CARTON (24338-300-65) > 60 SPRAY, METERED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:AEROSOL;SUBLINGUALStrength0.4MG/SPRAY
Approval Date:Oct 31, 1985TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;SUBLINGUALStrength0.4MG/SPRAY
Approval Date:Jan 10, 1997TE:ABRLD:Yes
Patent:7,872,049Patent Expiration:Mar 14, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:ANGINA PECTORIS

Expired Orange Book Patents for NDA: 018705

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pohl Boskamp
NITROLINGUAL PUMPSPRAY
nitroglycerin
SPRAY, METERED;SUBLINGUAL018705-002Jan 10, 19975,186,925► subscribe
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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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