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Dow
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Federal Trade Commission
Farmers Insurance
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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074642

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NDA 074642 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Epic Pharma, Mylan, Watson Labs, Exela Pharma Science, Luitpold Pharms Inc, Mylan Institutional, Navinta Llc, Sun Pharma Global, West-ward Pharms Int, and Wockhardt, and is included in twelve NDAs. It is available from nine suppliers. Additional details are available on the NICARDIPINE HYDROCHLORIDE profile page.

The generic ingredient in NICARDIPINE HYDROCHLORIDE is nicardipine hydrochloride. There are eleven drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 074642
Tradename:NICARDIPINE HYDROCHLORIDE
Applicant:Mylan
Ingredient:nicardipine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 074642
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074642 ANDA Mylan Pharmaceuticals Inc. 0378-1020 N 0378-1020-05
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074642 ANDA Mylan Pharmaceuticals Inc. 0378-1020 N 0378-1020-77

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Jul 18, 1996TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Jul 18, 1996TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cantor Fitzgerald
Moodys
US Army
AstraZeneca
Julphar
Teva
Argus Health
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