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Generated: December 14, 2018

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Details for New Drug Application (NDA): 074116

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NDA 074116 describes PIROXICAM, which is a drug marketed by Breckenridge Pharm, Cycle Pharms Ltd, Egis, Flamingo Pharms, Hikma Pharms, Ivax Sub Teva Pharms, Micro Labs, Mylan, Mylan Ireland Ltd, PII, SCS, Strides Pharma, Sun Pharm Industries, Teva, Teva Pharms, Unichem Labs Ltd, Watson Labs, and Zydus Pharms Usa Inc, and is included in twenty-three NDAs. It is available from twenty-three 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. Twenty-five suppliers are listed for this compound. Additional details are available on the piroxicam profile page.
Summary for 074116
Tradename:PIROXICAM
Applicant:Mylan Ireland Ltd
Ingredient:piroxicam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 074116
Medical Subject Heading (MeSH) Categories for 074116
Suppliers and Packaging for NDA: 074116
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIROXICAM piroxicam CAPSULE;ORAL 074116 ANDA Mylan Pharmaceuticals Inc. 0378-0466 0378-0466-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-0466-01)
PIROXICAM piroxicam CAPSULE;ORAL 074116 ANDA Rebel Distributors Corp 42254-143 42254-143-60 60 CAPSULE in 1 BOTTLE, PLASTIC (42254-143-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Jun 15, 1993TE:ABRLD:No

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