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Details for New Drug Application (NDA): 022276

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NDA 022276 describes NICARDIPINE HYDROCHLORIDE, which is a drug marketed by Sun Pharma Global, Eurohlth Intl Sarl, 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: 022276

Tradename:
NICARDIPINE HYDROCHLORIDE
Applicant:
Exela Pharma Science
Ingredient:
nicardipine hydrochloride
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022276

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 022276

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride
INJECTABLE;INJECTION 022276 NDA West-Ward Pharmaceuticals Corp 0143-9542 0143-9542-10 10 VIAL in 1 CARTON (0143-9542-10) > 10 mL in 1 VIAL (0143-9542-01)
NICARDIPINE HYDROCHLORIDE
nicardipine hydrochloride
INJECTABLE;INJECTION 022276 NDA West-Ward Pharmaceuticals Corp 0143-9593 0143-9593-10 10 VIAL in 1 CARTON (0143-9593-10) > 10 mL in 1 VIAL (0143-9593-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/10ML (2.5MG/ML)
Approval Date:Jul 24, 2008TE:APRLD:No


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