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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. Five suppliers are listed for this compound. Additional details are available on the nisoldipine profile page.

Summary for NDA: 091001

Tradename:
NISOLDIPINE
Applicant:
Mylan
Ingredient:
nisoldipine
Patents:0
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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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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