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Last Updated: August 14, 2020

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Details for New Drug Application (NDA): 207938

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NDA 207938 describes PIROXICAM, which is a drug marketed by Breckenridge, Cadila, Cycle Pharms Ltd, Egis, Flamingo Pharms, Hikma, Ivax Sub Teva Pharms, Micro Labs, Mylan, Nostrum Labs Inc, SCS, Strides Pharma, Sun Pharm Industries, Teva, Teva Pharms, Unichem Labs Ltd, and Watson Labs, and is included in twenty-three NDAs. It is available from sixteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the piroxicam profile page.
Summary for 207938
Tradename:PIROXICAM
Applicant:Flamingo Pharms
Ingredient:piroxicam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207938
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 207938
Suppliers and Packaging for NDA: 207938
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIROXICAM piroxicam CAPSULE;ORAL 207938 ANDA DIRECT RX 61919-193 61919-193-30 30 CAPSULE in 1 BOTTLE (61919-193-30)
PIROXICAM piroxicam CAPSULE;ORAL 207938 ANDA Proficient Rx LP 63187-972 63187-972-30 30 CAPSULE in 1 BOTTLE (63187-972-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength10MG
Approval Date:Sep 9, 2016TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Sep 9, 2016TE:ABRLD:No

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