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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 022276


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NDA 022276 describes NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE, which is a drug marketed by Cipla and Hikma Intl Pharms and is included in two NDAs. It is available from four suppliers. Additional details are available on the NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE profile page.

The generic ingredient in NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE 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 022276
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 Hikma Pharmaceuticals USA Inc. 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)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/10ML (2.5MG/ML)
Approval Date:Jul 24, 2008TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength20MG/200ML (0.1MG/ML)
Approval Date:Apr 7, 2016TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength40MG/200ML (0.2MG/ML)
Approval Date:Apr 7, 2016TE:APRLD:Yes

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