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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 079051


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NDA 079051 describes NISOLDIPINE, which is a drug marketed by Amta and Mylan and is included in three NDAs. It is available from one supplier. Additional details are available on the NISOLDIPINE profile page.

The generic ingredient in NISOLDIPINE is nisoldipine. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
Summary for 079051
Tradename:NISOLDIPINE
Applicant:Mylan
Ingredient:nisoldipine
Patents:0
Pharmacology for NDA: 079051
Mechanism of ActionCalcium Channel Antagonists
Physiological EffectDecreased Blood Pressure
Medical Subject Heading (MeSH) Categories for 079051
Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents
Suppliers and Packaging for NDA: 079051
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 079051 ANDA Mylan Pharmaceuticals Inc. 0378-2222 0378-2222-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2222-01)
NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 079051 ANDA Mylan Pharmaceuticals Inc. 0378-2223 0378-2223-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2223-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength20MG
Approval Date:Jul 25, 2008TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Jul 25, 2008TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength40MG
Approval Date:Jul 25, 2008TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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