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Generated: November 20, 2018

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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-eight drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 018482
Tradename:PROCARDIA
Applicant:Pfizer
Ingredient:nifedipine
Patents:0
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)

Profile for product number 001

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

Profile 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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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 US Patents for NDA 018482

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer PROCARDIA nifedipine CAPSULE;ORAL 018482-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Pfizer PROCARDIA nifedipine CAPSULE;ORAL 018482-002 Jul 24, 1986 ➤ Sign Up ➤ Sign Up
Pfizer PROCARDIA nifedipine CAPSULE;ORAL 018482-002 Jul 24, 1986 ➤ Sign Up ➤ Sign Up
Pfizer PROCARDIA nifedipine CAPSULE;ORAL 018482-001 Approved Prior to Jan 1, 1982 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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