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Serving 500+ biopharmaceutical companies globally:

Julphar
Covington
Johnson and Johnson
Citi
Deloitte
Daiichi Sankyo
Fuji
Fish and Richardson
Novartis
Federal Trade Commission

Generated: August 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 019478

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NDA 019478 describes ADALAT, which is a drug marketed by Bayer Pharms and Alvogen and is included in two NDAs. Additional details are available on the ADALAT profile page.

The generic ingredient in ADALAT is nifedipine. There are thirty-nine drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for NDA: 019478

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength10MG
Approval Date:Nov 27, 1985TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength20MG
Approval Date:Sep 17, 1986TE:RLD:No

Expired Orange Book Patents for NDA: 019478

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Pharms
ADALAT
nifedipine
CAPSULE;ORAL019478-001Nov 27, 1985► Subscribe► Subscribe
Bayer Pharms
ADALAT
nifedipine
CAPSULE;ORAL019478-002Sep 17, 1986► Subscribe► Subscribe
Bayer Pharms
ADALAT
nifedipine
CAPSULE;ORAL019478-001Nov 27, 1985► Subscribe► Subscribe
Bayer Pharms
ADALAT
nifedipine
CAPSULE;ORAL019478-002Sep 17, 1986► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Cipla
Medtronic
Covington
Fish and Richardson
Accenture
Federal Trade Commission
Harvard Business School
Queensland Health
Chubb
Julphar

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