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Details for New Drug Application (NDA): 208462
NDA 208462 describes NINLARO, which is a drug marketed by Millennium Pharms and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the NINLARO profile page.
The generic ingredient in NINLARO is ixazomib citrate. One supplier is listed for this compound. Additional details are available on the ixazomib citrate profile page.
The generic ingredient in NINLARO is ixazomib citrate. One supplier is listed for this compound. Additional details are available on the ixazomib citrate profile page.
Summary for 208462
| Tradename: | NINLARO |
| Applicant: | Millennium Pharms |
| Ingredient: | ixazomib citrate |
| Patents: | 9 |
Pharmacology for NDA: 208462
| Mechanism of Action | Proteasome Inhibitors |
Suppliers and Packaging for NDA: 208462
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462 | NDA | Millennium Pharmaceuticals, Inc. | 63020-078 | N | 63020-078-02 |
| NINLARO | ixazomib citrate | CAPSULE;ORAL | 208462 | NDA | Millennium Pharmaceuticals, Inc. | 63020-079 | N | 63020-079-02 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 2.3MG BASE | ||||
| Approval Date: | Nov 20, 2015 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 20, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Nov 20, 2022 | ||||||||
| Regulatory Exclusivity Use: | USE IN COMBINATION WITH LENALIDOMIDE AND DEXAMETHASONE FOR THE TREATMENT OFPATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Aug 6, 2027 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD FOR TREATING CANCER, INCLUDING MULTIPLE MYELOMA | ||||||||
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