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Last Updated: April 26, 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-six 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

Medical Subject Heading (MeSH) Categories for 018482

Calcium Channel Blockers
Tocolytic Agents
Vasodilator Agents

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:	RX	Dosage:	CAPSULE;ORAL			Strength	10MG
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jul 24, 1986	TE:		RLD:	Yes

Expired US Patents for NDA 018482

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

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