Details for New Drug Application (NDA): 211728
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NDA 211728 describes JELMYTO, which is a drug marketed by Urogen Pharma and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the JELMYTO profile page.
The generic ingredient in JELMYTO is mitomycin. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
The generic ingredient in JELMYTO is mitomycin. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mitomycin profile page.
Summary for 211728
| Tradename: | JELMYTO |
| Applicant: | Urogen Pharma |
| Ingredient: | mitomycin |
| Patents: | 2 |
Medical Subject Heading (MeSH) Categories for 211728
Suppliers and Packaging for NDA: 211728
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JELMYTO | mitomycin | POWDER;PYELOCALYCEAL | 211728 | NDA | UroGen Pharma, Inc. | 72493-103 | 72493-103-03 | 1 KIT in 1 CARTON (72493-103-03) * 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (72493-101-40) * 20 mL in 1 VIAL, SINGLE-DOSE (72493-102-20) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;PYELOCALYCEAL | Strength | 40MG/VIAL | ||||
| Approval Date: | Apr 15, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 15, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH LOW-GRADE UPPER TRACT UROTHELIAL CANCER (LG-UTUC) | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 20, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 20, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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