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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 218202


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NDA 218202 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 218202
Tradename:NICARDIPINE HYDROCHLORIDE
Applicant:Skg Pharma
Ingredient:nicardipine hydrochloride
Patents:0
Suppliers and Packaging for NDA: 218202
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 218202 ANDA Amneal Pharmaceuticals NY LLC 69238-2691 69238-2691-1 90 CAPSULE in 1 BOTTLE (69238-2691-1)
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 218202 ANDA Amneal Pharmaceuticals NY LLC 69238-2692 69238-2692-1 90 CAPSULE in 1 BOTTLE (69238-2692-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Apr 10, 2024TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Apr 10, 2024TE:ABRLD:No

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