Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

DrugPatentWatch Database Preview

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 Exela Pharma Science and is included in one NDA. It is available from one supplier. 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. Seven suppliers are listed for this compound. Additional details are available on the nicardipine hydrochloride profile page.
Summary for 022276
Tradename:NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE
Applicant:Exela Pharma Science
Ingredient:nicardipine hydrochloride
Patents:0
Formulation / Manufacturing:see details
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)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrength20MG/200ML (0.1MG/ML)
Approval Date:Apr 7, 2016TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INTRAVENOUSStrength40MG/200ML (0.2MG/ML)
Approval Date:Apr 7, 2016TE:RLD:No

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