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Details for New Drug Application (NDA): 074118

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NDA 074118 describes PIROXICAM, which is a drug marketed by Mylan, Teva Pharms, Egis, Mylan Ireland Ltd, Teva, Mutual Pharm, SCS, Sun Pharm Inds, Flamingo Pharms, Ivax Sub Teva Pharms, Cycle Pharms Ltd, and Watson Labs, and is included in seventeen NDAs. It is available from twenty-two suppliers. Additional details are available on the PIROXICAM profile page.

The generic ingredient in PIROXICAM 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: 074118

Tradename:
PIROXICAM
Applicant:
Mylan Ireland Ltd
Ingredient:
piroxicam
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 074118

Suppliers and Packaging for NDA: 074118

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIROXICAM
piroxicam
CAPSULE;ORAL 074118 ANDA Mylan Pharmaceuticals Inc. 0378-0467 0378-0467-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-0467-01)
PIROXICAM
piroxicam
CAPSULE;ORAL 074118 ANDA Mylan Pharmaceuticals Inc. 0378-0467 0378-0467-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-0467-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Jun 15, 1993TE:ABRLD:No


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