Details for New Drug Application (NDA): 208340
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NDA 208340 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.
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.
Pharmacology for NDA: 208340
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 208340
Suppliers and Packaging for NDA: 208340
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIROXICAM | piroxicam | CAPSULE;ORAL | 208340 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-255 | 29300-255-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (29300-255-01) |
| PIROXICAM | piroxicam | CAPSULE;ORAL | 208340 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-255 | 29300-255-05 | 500 CAPSULE in 1 BOTTLE, PLASTIC (29300-255-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 13, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Apr 13, 2017 | TE: | AB | RLD: | No | ||||
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