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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 217555


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NDA 217555 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 217555
Tradename:NICARDIPINE HYDROCHLORIDE
Applicant:Bionpharma
Ingredient:nicardipine hydrochloride
Patents:0
Suppliers and Packaging for NDA: 217555
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 217555 ANDA Bionpharma Inc. 69452-436 69452-436-19 90 CAPSULE in 1 BOTTLE, PLASTIC (69452-436-19)
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 217555 ANDA Bionpharma Inc. 69452-437 69452-437-19 90 CAPSULE in 1 BOTTLE, PLASTIC (69452-437-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:May 3, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:May 3, 2023TE:ABRLD:No

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