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Generated: March 17, 2018

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Details for New Drug Application (NDA): 078714

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NDA 078714 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. Fourteen suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 078714
Applicant:West-ward Pharms Int
Ingredient:nicardipine hydrochloride
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 078714

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/10ML (2.5MG/ML)
Approval Date:Dec 28, 2009TE:APRLD:No

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