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Last Updated: July 15, 2024

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 one supplier. 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. Thirty-seven suppliers are listed for this compound. Additional details are available on the nifedipine profile page.
Summary for 018482
Formulation / Manufacturing:see details
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 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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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