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Serving leading biopharmaceutical companies globally:

Accenture
Daiichi Sankyo
Farmers Insurance
Healthtrust
Harvard Business School
Boehringer Ingelheim
Baxter
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Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018482

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NDA 018482 describes PROCARDIA, which is a drug marketed by Pfizer and is included in two NDAs. It is available from two suppliers. Additional details are available on the PROCARDIA profile page.

The generic ingredient in PROCARDIA 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 018482

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

Pharmacology for NDA: 018482

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for 018482

Suppliers and Packaging for NDA: 018482

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROCARDIA nifedipine CAPSULE;ORAL 018482 NDA Pfizer Laboratories Div Pfizer Inc 0069-2600 0069-2600-66 100 CAPSULE in 1 BOTTLE (0069-2600-66)
PROCARDIA nifedipine CAPSULE;ORAL 018482 NDA AUTHORIZED GENERIC Greenstone LLC 59762-1004 59762-1004-1 100 CAPSULE in 1 BOTTLE (59762-1004-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 24, 1986TE:RLD:Yes

Expired Orange Book Patents for NDA: 018482

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
PfizerPROCARDIAnifedipineCAPSULE;ORAL018482-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
PfizerPROCARDIAnifedipineCAPSULE;ORAL018482-002Jul 24, 1986► Subscribe► Subscribe
PfizerPROCARDIAnifedipineCAPSULE;ORAL018482-002Jul 24, 1986► Subscribe► Subscribe
PfizerPROCARDIAnifedipineCAPSULE;ORAL018482-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Healthtrust
Express Scripts
Harvard Business School
Dow
Colorcon
QuintilesIMS
Chinese Patent Office
Johnson and Johnson
Boehringer Ingelheim
Argus Health

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