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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 eight 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. Fifty-one suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for NDA: 019684

Tradename:
PROCARDIA XL
Applicant:
Pfizer
Ingredient:
nifedipine
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 019684

Ingredient-typeDihydropyridines
Mechanism of ActionCalcium Channel Antagonists

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Sep 6, 1989TE:AB2RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Sep 6, 1989TE:AB2RLD:No

Summary for product number 003

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

Expired Orange Book Patents for NDA: 019684

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
PROCARDIA XL
nifedipine
TABLET, EXTENDED RELEASE;ORAL019684-003Sep 6, 19894,327,725► subscribe
Pfizer
PROCARDIA XL
nifedipine
TABLET, EXTENDED RELEASE;ORAL019684-003Sep 6, 19895,264,446► subscribe
Pfizer
PROCARDIA XL
nifedipine
TABLET, EXTENDED RELEASE;ORAL019684-001Sep 6, 19894,327,725► subscribe
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