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Generated: May 29, 2017

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Details for New Drug Application (NDA): 091001

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NDA 091001 describes NISOLDIPINE, which is a drug marketed by Mylan and is included in two 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. Six suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.

Summary for NDA: 091001

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091001

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
Physiological EffectDecreased Blood Pressure

Suppliers and Packaging for NDA: 091001

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NISOLDIPINE
nisoldipine
TABLET, EXTENDED RELEASE;ORAL 091001 ANDA Mylan Pharmaceuticals Inc. 0378-2096 0378-2096-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2096-01)
NISOLDIPINE
nisoldipine
TABLET, EXTENDED RELEASE;ORAL 091001 ANDA Mylan Pharmaceuticals Inc. 0378-2097 0378-2097-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-2097-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength8.5MG
Approval Date:Jan 26, 2011TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength17MG
Approval Date:Jan 26, 2011TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength25.5MG
Approval Date:Jan 26, 2011TE:RLD:No


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