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Generated: April 23, 2019

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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 five suppliers. 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. Forty-eight 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 019684
Mechanism of ActionCalcium Channel Antagonists
Medical Subject Heading (MeSH) Categories for 019684
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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Sep 6, 1989TE:AB2RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Sep 6, 1989TE:AB2RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength90MG
Approval Date:Sep 6, 1989TE:AB2RLD:Yes

Expired US Patents for NDA 019684

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 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer PROCARDIA XL nifedipine TABLET, EXTENDED RELEASE;ORAL 019684-002 Sep 6, 1989 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer PROCARDIA XL nifedipine TABLET, EXTENDED RELEASE;ORAL 019684-001 Sep 6, 1989 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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