Details for New Drug Application (NDA): 211950
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NDA 211950 describes XIPERE, which is a drug marketed by Bausch And Lomb Inc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the XIPERE profile page.
The generic ingredient in XIPERE is triamcinolone acetonide. There are fifty-one drug master file entries for this compound. Sixty-nine 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 are fifty-one drug master file entries for this compound. Sixty-nine 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: | 3 |
| Formulation / Manufacturing: | see details |
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 | |||||
| Regulatory Exclusivity Expiration: | Oct 22, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 2, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MACULAR EDEMA ASSOCIATED WITH UVEITIS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Nov 8, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MACULAR EDEMA ASSOCIATED WITH UVEITIS | ||||||||
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