Details for New Drug Application (NDA): 219469
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NDA 219469 describes LYNKUET, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. Additional details are available on the LYNKUET profile page.
The generic ingredient in LYNKUET is elinzanetant. One supplier is listed for this compound. Additional details are available on the elinzanetant profile page.
The generic ingredient in LYNKUET is elinzanetant. One supplier is listed for this compound. Additional details are available on the elinzanetant profile page.
Summary for 219469
| Tradename: | LYNKUET |
| Applicant: | Bayer Hlthcare |
| Ingredient: | elinzanetant |
| Patents: | 0 |
Suppliers and Packaging for NDA: 219469
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LYNKUET | elinzanetant | CAPSULE;ORAL | 219469 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-475 | 50419-475-05 | 5 BLISTER PACK in 1 CARTON (50419-475-05) / 12 CAPSULE in 1 BLISTER PACK (50419-475-01) |
| LYNKUET | elinzanetant | CAPSULE;ORAL | 219469 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-475 | 50419-475-72 | 2 BLISTER PACK in 1 CARTON (50419-475-72) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 60MG | ||||
| Approval Date: | Oct 24, 2025 | TE: | RLD: | Yes | |||||
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