Details for New Drug Application (NDA): 218395
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NDA 218395 describes XIFYRM, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the XIFYRM profile page.
The generic ingredient in XIFYRM is meloxicam. There are twenty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the meloxicam profile page.
The generic ingredient in XIFYRM is meloxicam. There are twenty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the meloxicam profile page.
Pharmacology for NDA: 218395
| Mechanism of Action | Cyclooxygenase Inhibitors |
Suppliers and Packaging for NDA: 218395
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XIFYRM | meloxicam | SOLUTION;INTRAVENOUS | 218395 | NDA | Azurity Pharmaceuticals, Inc. | 24338-153 | 24338-153-02 | 10 VIAL, SINGLE-DOSE in 1 CARTON (24338-153-02) / 1 mL in 1 VIAL, SINGLE-DOSE (24338-153-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 30MG/ML (30MG/ML) | ||||
| Approval Date: | Jun 5, 2025 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 31, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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