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Last Updated: September 26, 2020

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Details for New Drug Application (NDA): 074928

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NDA 074928 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms Inc, Epic Pharma, Mylan, Am Regent, Exela Pharma Science, Mylan Institutional, Navinta Llc, Sun Pharma Global, West-ward Pharms Int, and Wockhardt, and is included in twelve NDAs. It is available from eight 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. Nine suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 074928
Tradename:NICARDIPINE HYDROCHLORIDE
Applicant:Epic Pharma
Ingredient:nicardipine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 074928
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074928 ANDA PuraCap Laboratories LLC dba Blu Pharmaceuticals 24658-750 24658-750-90 90 CAPSULE in 1 BOTTLE (24658-750-90)
NICARDIPINE HYDROCHLORIDE nicardipine hydrochloride CAPSULE;ORAL 074928 ANDA PuraCap Laboratories LLC dba Blu Pharmaceuticals 24658-751 24658-751-90 90 CAPSULE in 1 BOTTLE (24658-751-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Mar 19, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Mar 19, 1998TE:ABRLD:No

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