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Last Updated: November 7, 2024

Details for New Drug Application (NDA): 216606


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NDA 216606 describes NISOLDIPINE, which is a drug marketed by Amta and Mylan and is included in three NDAs. It is available from two suppliers. 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. Four suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.
Summary for 216606
Tradename:NISOLDIPINE
Applicant:Amta
Ingredient:nisoldipine
Patents:0
Pharmacology for NDA: 216606
Mechanism of ActionCalcium Channel Antagonists
Physiological EffectDecreased Blood Pressure
Medical Subject Heading (MeSH) Categories for 216606
Suppliers and Packaging for NDA: 216606
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NISOLDIPINE nisoldipine TABLET, EXTENDED RELEASE;ORAL 216606 ANDA Utopic Pharmaceuticals Inc 84063-001 84063-001-04 1 BOTTLE in 1 CARTON (84063-001-04) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength8.5MG
Approval Date:Apr 10, 2023TE:RLD:No

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