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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 217548


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NDA 217548 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-one 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-three suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 217548
Tradename:NICARDIPINE HYDROCHLORIDE
Applicant:Chengdu Shuode
Ingredient:nicardipine hydrochloride
Patents:0
Suppliers and Packaging for NDA: 217548
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 217548 ANDA Fresenius Kabi USA, LLC 65219-818 65219-818-10 1 VIAL, GLASS in 1 CARTON (65219-818-10) / 10 mL in 1 VIAL, GLASS
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride INJECTABLE;INJECTION 217548 ANDA Chengdu Shuode Pharmaceutical Co., Ltd 82432-103 82432-103-01 1 VIAL, GLASS in 1 CARTON (82432-103-01) / 10 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/10ML (2.5MG/ML)
Approval Date:Sep 6, 2024TE:APRLD:No

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