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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 020198


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NDA 020198 describes ADALAT CC, which is a drug marketed by Alvogen and is included in one NDA. It is available from one supplier. Additional details are available on the ADALAT CC profile page.

The generic ingredient in ADALAT CC is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 020198
Tradename:ADALAT CC
Applicant:Alvogen
Ingredient:nifedipine
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 020198
Suppliers and Packaging for NDA: 020198
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-0695 50090-0695-0 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-0695-0)
ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198 NDA AUTHORIZED GENERIC A-S Medication Solutions 50090-0695 50090-0695-2 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-0695-2)
Paragraph IV (Patent) Challenges for 020198
Tradename Dosage Ingredient NDA Submissiondate
ADALAT CC TABLET, EXTENDED RELEASE;ORAL nifedipine 020198

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Apr 21, 1993TE:AB1RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Apr 21, 1993TE:AB1RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Apr 21, 1993TE:AB1RLD:Yes

Expired US Patents for NDA 020198

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-003 Apr 21, 1993   Start Trial   Start Trial
Alvogen ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-003 Apr 21, 1993   Start Trial   Start Trial
Alvogen ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-001 Apr 21, 1993   Start Trial   Start Trial
Alvogen ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-002 Apr 21, 1993   Start Trial   Start Trial
Alvogen ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-002 Apr 21, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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