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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Covington
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Cantor Fitzgerald
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US Army
Argus Health
Express Scripts

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090671

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NDA 090671 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 thirteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

Summary for 090671

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 090671

Suppliers and Packaging for NDA: 090671

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 090671 ANDA Wockhardt Limited 55648-631 55648-631-02 10 CARTON in 1 CARTON (55648-631-02) > 1 VIAL, SINGLE-DOSE in 1 CARTON (55648-631-01) > 10 mL in 1 VIAL, SINGLE-DOSE
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 090671 ANDA Wockhardt USA LLC. 64679-631 64679-631-02 10 CARTON in 1 CARTON (64679-631-02) > 1 VIAL, SINGLE-DOSE in 1 CARTON (64679-631-01) > 10 mL in 1 VIAL, SINGLE-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/10ML (2.5MG/ML)
Approval Date:Nov 17, 2009TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Merck
Federal Trade Commission
Baxter
Fish and Richardson
Cerilliant
Fuji
McKesson
Colorcon
Chinese Patent Office
Chubb

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