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Last Updated: January 23, 2021

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Details for New Drug Application (NDA): 020212

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NDA 020212 describes ZINECARD, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from one supplier. Additional details are available on the ZINECARD profile page.

The generic ingredient in ZINECARD is dexrazoxane hydrochloride. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the dexrazoxane hydrochloride profile page.
Summary for 020212
Tradename:ZINECARD
Applicant:Pharmacia And Upjohn
Ingredient:dexrazoxane hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020212
Medical Subject Heading (MeSH) Categories for 020212
Suppliers and Packaging for NDA: 020212
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZINECARD dexrazoxane hydrochloride INJECTABLE;INJECTION 020212 NDA Pharmacia and Upjohn Company LLC 0013-8717 0013-8717-62 1 VIAL, SINGLE-DOSE in 1 CARTON (0013-8717-62) > 25 mL in 1 VIAL, SINGLE-DOSE
Paragraph IV (Patent) Challenges for 020212
Tradename Dosage Ingredient NDA Submissiondate
ZINECARD INJECTABLE;INJECTION dexrazoxane hydrochloride 020212

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 250MG BASE/VIAL
Approval Date:May 26, 1995TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:May 26, 1995TE:APRLD:Yes

Expired US Patents for NDA 020212

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn ZINECARD dexrazoxane hydrochloride INJECTABLE;INJECTION 020212-002 May 26, 1995   Start Trial   Start Trial
Pharmacia And Upjohn ZINECARD dexrazoxane hydrochloride INJECTABLE;INJECTION 020212-001 May 26, 1995   Start Trial   Start Trial
Pharmacia And Upjohn ZINECARD dexrazoxane hydrochloride INJECTABLE;INJECTION 020212-001 May 26, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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