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Details for New Drug Application (NDA): 019734

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NDA 019734 describes CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, which is a drug marketed by Chiesi Usa Inc and is included in one NDA. It is available from three suppliers. There are four patents protecting this drug. Additional details are available on the CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER profile page.

The generic ingredient in CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER 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: 019734

Tradename:
CARDENE
Applicant:
Chiesi Usa Inc
Ingredient:
nicardipine hydrochloride
Patents:4
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019734

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 019734

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARDENE
nicardipine hydrochloride
INJECTABLE;INJECTION 019734 NDA Chiesi USA, Inc. 10122-313 10122-313-10 10 CARTON in 1 BOX (10122-313-10) > 1 BAG in 1 CARTON (10122-313-01) > 200 mL in 1 BAG
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
nicardipine hydrochloride
INJECTABLE;INTRAVENOUS 019734 NDA Chiesi USA, Inc. 10122-313 10122-313-10 10 CARTON in 1 BOX (10122-313-10) > 1 BAG in 1 CARTON (10122-313-01) > 200 mL in 1 BAG

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength25MG/10ML (2.5MG/ML)
Approval Date:Jan 30, 1992TE:APRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength20MG/200ML (0.1MG/ML)
Approval Date:Jul 31, 2008TE:RLD:Yes
Patent:7,612,102Patent Expiration:Dec 26, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:9,364,564Patent Expiration:Dec 26, 2027Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 019734

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
INJECTABLE;INJECTION019734-001Jan 30, 19923,985,758► subscribe
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
INJECTABLE;INJECTION019734-001Jan 30, 19925,164,405► subscribe
Chiesi Usa Inc
CARDENE
nicardipine hydrochloride
INJECTABLE;INJECTION019734-001Jan 30, 19924,880,823► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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