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Generated: May 23, 2017

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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 Sun Pharma Global, West-ward Pharms Int, Navinta Llc, Epic Pharma, Luitpold Pharms Inc, Ani Pharms Inc, Mylan, Mylan Institutional, Watson Labs, Wockhardt, and Exela Pharma Science, and is included in twelve NDAs. It is available from fourteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.

Summary for NDA: 074928

Therapeutic Class:Cardiovascular Agents
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
CAPSULE;ORAL 074928 ANDA PuraCap Laboratories, LLC 24658-750 24658-750-90 90 CAPSULE in 1 BOTTLE (24658-750-90)
nicardipine hydrochloride
CAPSULE;ORAL 074928 ANDA PuraCap Laboratories, LLC 24658-751 24658-751-90 90 CAPSULE in 1 BOTTLE (24658-751-90)

Summary for product number 001

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

Summary for product number 002

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

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