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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 019684

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NDA 019684 describes PROCARDIA XL, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the PROCARDIA XL profile page.

The generic ingredient in PROCARDIA XL 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 019684

Tradename:	PROCARDIA XL
Applicant:	Pfizer
Ingredient:	nifedipine
Patents:	0

Pharmacology for NDA: 019684

Mechanism of Action	Calcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for 019684

Calcium Channel Blockers
Tocolytic Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 019684

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684	NDA	Pfizer Laboratories Div Pfizer Inc	0069-2650	0069-2650-41	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0069-2650-41)
PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684	NDA	Pfizer Laboratories Div Pfizer Inc	0069-2650	0069-2650-66	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-2650-66)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	30MG
Approval Date:	Sep 6, 1989	TE:	AB2	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	60MG
Approval Date:	Sep 6, 1989	TE:	AB2	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	90MG
Approval Date:	Sep 6, 1989	TE:	AB2	RLD:	Yes

Expired US Patents for NDA 019684

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989	5,264,446	⤷ Get Started Free
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989	4,783,337	⤷ Get Started Free
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-001	Sep 6, 1989	5,264,446	⤷ Get Started Free
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989	4,783,337	⤷ Get Started Free
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-001	Sep 6, 1989	4,327,725	⤷ Get Started Free
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989	5,264,446	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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