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Serving 500+ biopharmaceutical companies globally:

Colorcon
US Department of Justice
Citi
Express Scripts
Fuji
Deloitte
Covington
Cantor Fitzgerald
Julphar
Cipla

Generated: August 17, 2017

DrugPatentWatch Database Preview

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 seven 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-three suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

Summary for NDA: 019684

Tradename:
1
Applicant:
1
Ingredient:
1
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:Yes

Summary for product number 002

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

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;ORAL019684-002Sep 6, 1989► Subscribe► Subscribe
Pfizer
PROCARDIA XL
nifedipine
TABLET, EXTENDED RELEASE;ORAL019684-003Sep 6, 1989► Subscribe► Subscribe
Pfizer
PROCARDIA XL
nifedipine
TABLET, EXTENDED RELEASE;ORAL019684-001Sep 6, 1989► Subscribe► Subscribe
Pfizer
PROCARDIA XL
nifedipine
TABLET, EXTENDED RELEASE;ORAL019684-003Sep 6, 1989► Subscribe► Subscribe
Pfizer
PROCARDIA XL
nifedipine
TABLET, EXTENDED RELEASE;ORAL019684-002Sep 6, 1989► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Accenture
UBS
Teva
Johnson and Johnson
Boehringer Ingelheim
Dow
McKesson
Deloitte
US Department of Justice
Chinese Patent Office

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