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Generated: December 16, 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-three suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for 019478

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

Medical Subject Heading (MeSH) Categories for 019478

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 PharmsADALATnifedipineCAPSULE;ORAL019478-001Nov 27, 1985► Subscribe► Subscribe
Bayer PharmsADALATnifedipineCAPSULE;ORAL019478-002Sep 17, 1986► Subscribe► Subscribe
Bayer PharmsADALATnifedipineCAPSULE;ORAL019478-002Sep 17, 1986► Subscribe► Subscribe
Bayer PharmsADALATnifedipineCAPSULE;ORAL019478-001Nov 27, 1985► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Department of Justice
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McKesson
Dow
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Novartis
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Boehringer Ingelheim
Argus Health
Moodys

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