Details for New Drug Application (NDA): 218543
NDA 218543 describes MIRABEGRON, which is a drug marketed by Alkem Labs Ltd, Apotex, Creekwood Pharms, Deva Holding As, Lupin, MSN, Qilu, Sawai Usa, and Zydus Pharms, and is included in eleven NDAs. It is available from nine suppliers. Additional details are available on the MIRABEGRON profile page.
The generic ingredient in MIRABEGRON is mirabegron. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the mirabegron profile page.
The generic ingredient in MIRABEGRON is mirabegron. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the mirabegron profile page.
Summary for 218543
| Tradename: | MIRABEGRON |
| Applicant: | Msn |
| Ingredient: | mirabegron |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218543
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 218543 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2860 | 69238-2860-1 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69238-2860-1) |
| MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 218543 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-2860 | 69238-2860-2 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69238-2860-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG | ||||
| Approval Date: | Nov 4, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG | ||||
| Approval Date: | Nov 4, 2025 | TE: | AB | RLD: | No | ||||
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