Details for New Drug Application (NDA): 205585
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NDA 205585 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.
Summary for 205585
| Tradename: | PIROXICAM |
| Applicant: | Zydus Lifesciences |
| Ingredient: | piroxicam |
| Patents: | 0 |
Pharmacology for NDA: 205585
| Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 205585
Suppliers and Packaging for NDA: 205585
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIROXICAM | piroxicam | CAPSULE;ORAL | 205585 | ANDA | Zydus Lifesciences Limited | 70771-1429 | 70771-1429-0 | 1000 CAPSULE in 1 BOTTLE (70771-1429-0) |
| PIROXICAM | piroxicam | CAPSULE;ORAL | 205585 | ANDA | Zydus Lifesciences Limited | 70771-1429 | 70771-1429-1 | 100 CAPSULE in 1 BOTTLE (70771-1429-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 17, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 20MG | ||||
| Approval Date: | Jul 17, 2018 | TE: | AB | RLD: | No | ||||
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