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

Summary for NDA: 018482

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 018482

Mechanism of ActionCalcium Channel Antagonists

Suppliers and Packaging for NDA: 018482

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 018482 NDA Pfizer Laboratories Div Pfizer Inc 0069-2600 0069-2600-66 100 CAPSULE in 1 BOTTLE (0069-2600-66)
CAPSULE;ORAL 018482 NDA REMEDYREPACK INC. 52125-126 52125-126-02 30 CAPSULE in 1 BLISTER PACK (52125-126-02)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength20MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jul 24, 1986TE:RLD:No

Expired Orange Book Patents for NDA: 018482

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CAPSULE;ORAL018482-001Approved Prior to Jan 1, 19823,644,627► subscribe
CAPSULE;ORAL018482-001Approved Prior to Jan 1, 19823,784,684► subscribe
CAPSULE;ORAL018482-002Jul 24, 19863,784,684► subscribe
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