Details for New Drug Application (NDA): 219097
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NDA 219097 describes IMKELDI, which is a drug marketed by Shorla Oncology 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 IMKELDI profile page.
The generic ingredient in IMKELDI is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
The generic ingredient in IMKELDI is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 219097
| Tradename: | IMKELDI |
| Applicant: | Shorla Oncology |
| Ingredient: | imatinib mesylate |
| Patents: | 1 |
Suppliers and Packaging for NDA: 219097
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| IMKELDI | imatinib mesylate | SOLUTION;ORAL | 219097 | NDA | Shorla Oncology Inc., | 81927-201 | 81927-201-01 | 140 mL in 1 BOTTLE (81927-201-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 80MG BASE/ML | ||||
| Approval Date: | Nov 22, 2024 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try for Free | Patent Expiration: | Apr 27, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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