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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 074131


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NDA 074131 describes PIROXICAM, which is a drug marketed by Breckenridge, Cycle, Egis, Flamingo Pharms, Hikma, Ivax Sub Teva Pharms, Micro Labs, Mylan, Norvium Bioscience, Nostrum Labs Inc, SCS, Strides Pharma, Sun Pharm Industries, Teva, Teva Pharms, Unichem, Watson Labs, and Zydus Lifesciences, and is included in twenty-two NDAs. It is available from twelve suppliers. Additional details are available on the PIROXICAM profile page.

The generic ingredient in PIROXICAM is piroxicam. There are sixteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the piroxicam profile page.
Summary for 074131
Tradename:PIROXICAM
Applicant:Teva
Ingredient:piroxicam
Patents:0
Pharmacology for NDA: 074131
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 074131
Suppliers and Packaging for NDA: 074131
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIROXICAM piroxicam CAPSULE;ORAL 074131 ANDA Teva Pharmaceuticals USA, Inc. 0093-0756 0093-0756-01 100 CAPSULE in 1 BOTTLE (0093-0756-01)
PIROXICAM piroxicam CAPSULE;ORAL 074131 ANDA Teva Pharmaceuticals USA, Inc. 0093-0757 0093-0757-01 100 CAPSULE in 1 BOTTLE (0093-0757-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Dec 11, 1992TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Dec 11, 1992TE:ABRLD:No

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