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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Colorcon
Citi
Medtronic
QuintilesIMS
US Army
Cerilliant
Healthtrust
Moodys

Generated: June 19, 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 twelve 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. Thirteen 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:

Queensland Health
Merck
McKinsey
Express Scripts
Covington
Mallinckrodt
Healthtrust
Baxter
Colorcon

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