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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Colorcon
Moodys
Covington
Julphar
Merck
Boehringer Ingelheim
UBS
Federal Trade Commission

Generated: June 25, 2018

DrugPatentWatch Database Preview

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 four suppliers. 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. Forty-nine 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
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 020198
Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists
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 Alvogen Inc. 47781-368 N 47781-368-01
ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198 NDA AUTHORIZED GENERIC Alvogen Inc. 47781-369 N 47781-369-01

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

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Healthtrust
AstraZeneca
Johnson and Johnson
Colorcon
McKinsey
Chinese Patent Office
Julphar
Harvard Business School

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