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Details for New Drug Application (NDA): 018147

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NDA 018147 describes FELDENE, which is a drug marketed by Pfizer and is included in one NDA. It is available from three suppliers. Additional details are available on the FELDENE profile page.

The generic ingredient in FELDENE is piroxicam. There are fifteen drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the piroxicam profile page.

Summary for NDA: 018147

Therapeutic Class:Analgesics
Anti-inflammatory Agents

Pharmacology for NDA: 018147

Suppliers and Packaging for NDA: 018147

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 018147 NDA Pfizer Laboratories Div Pfizer Inc 0069-3220 0069-3220-66 100 CAPSULE in 1 BOTTLE (0069-3220-66)
CAPSULE;ORAL 018147 NDA Pfizer Laboratories Div Pfizer Inc 0069-3230 0069-3230-66 100 CAPSULE in 1 BOTTLE (0069-3230-66)

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Apr 6, 1982TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Apr 6, 1982TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018147

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CAPSULE;ORAL018147-002Apr 6, 19823,862,319<disabled>
CAPSULE;ORAL018147-003Apr 6, 19824,100,347<disabled>
CAPSULE;ORAL018147-002Apr 6, 19823,591,564<disabled>
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