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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 090671


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NDA 090671 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Bionpharma, Epic Pharma Llc, Glenmark Pharms Ltd, Norvium Bioscience, Senores Pharms, Skg Pharma, Am Regent, Chengdu Shuode, Eugia Pharma, Hikma Intl Pharms, Micro Labs, Navinta Llc, Rk Pharma, Sun Pharm, West-ward Pharms Int, Wockhardt, Inforlife, and Cipla, and is included in twenty-one NDAs. It is available from twenty-two 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. Twenty-four suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 090671
Tradename:NICARDIPINE HYDROCHLORIDE
Applicant:Wockhardt
Ingredient:nicardipine hydrochloride
Patents:0
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 USA LLC. 64679-631 64679-631-02 10 VIAL, SINGLE-DOSE in 1 CARTON (64679-631-02) / 10 mL in 1 VIAL, SINGLE-DOSE (64679-631-03)

Profile 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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