Details for New Drug Application (NDA): 211950
NDA 211950 describes XIPERE, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the XIPERE profile page.
The generic ingredient in XIPERE is triamcinolone acetonide. There is one drug master file entry for this compound. Eighty suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
The generic ingredient in XIPERE is triamcinolone acetonide. There is one drug master file entry for this compound. Eighty suppliers are listed for this compound. Additional details are available on the triamcinolone acetonide profile page.
Summary for 211950
| Tradename: | XIPERE |
| Applicant: | Bausch And Lomb Inc |
| Ingredient: | triamcinolone acetonide |
| Patents: | 4 |
Pharmacology for NDA: 211950
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 211950
Suppliers and Packaging for NDA: 211950
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XIPERE | triamcinolone acetonide | SUSPENSION;INJECTION | 211950 | NDA | Bausch & Lomb Incorporated | 24208-040 | 24208-040-01 | 1 TRAY in 1 CARTON (24208-040-01) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-02) |
| XIPERE | triamcinolone acetonide | SUSPENSION;INJECTION | 211950 | NDA | Bausch & Lomb Incorporated | 24208-040 | 24208-040-40 | 1 TRAY in 1 CARTON (24208-040-40) / 1 VIAL in 1 TRAY / .9 mL in 1 VIAL (24208-040-41) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION;INJECTION | Strength | 40MG/ML | ||||
| Approval Date: | Oct 22, 2021 | TE: | RLD: | Yes | |||||
| Patent: | 12,419,833 | Patent Expiration: | Apr 16, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF MACULAR EDEMA ASSOCIATED WITH UVEITIS | ||||||||
| Patent: | 8,636,713 | Patent Expiration: | May 2, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MACULAR EDEMA ASSOCIATED WITH UVEITIS | ||||||||
| Patent: | 9,636,332 | Patent Expiration: | Nov 8, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MACULAR EDEMA ASSOCIATED WITH UVEITIS | ||||||||
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