Details for New Drug Application (NDA): 215948
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NDA 215948 describes MIRABEGRON, which is a drug marketed by Alkem Labs Ltd, Lupin Ltd, Sawai Usa, and Zydus Pharms, and is included in four NDAs. It is available from three suppliers. Additional details are available on the MIRABEGRON profile page.
The generic ingredient in MIRABEGRON is mirabegron. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the mirabegron profile page.
The generic ingredient in MIRABEGRON is mirabegron. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the mirabegron profile page.
Summary for 215948
| Tradename: | MIRABEGRON |
| Applicant: | Alkem Labs Ltd |
| Ingredient: | mirabegron |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 12, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG | ||||
| Approval Date: | Feb 12, 2024 | TE: | AB | RLD: | No | ||||
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