Details for New Drug Application (NDA): 209485
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NDA 209485 describes MIRABEGRON, which is a drug marketed by Alkem Labs Ltd, Apotex, Deva Holding As, Lupin, MSN, Qilu, Sawai Usa, and Zydus Pharms, and is included in ten NDAs. It is available from eight 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. Nine 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. Nine suppliers are listed for this compound. Additional details are available on the mirabegron profile page.
Summary for 209485
| Tradename: | MIRABEGRON |
| Applicant: | Lupin |
| Ingredient: | mirabegron |
| Patents: | 0 |
Suppliers and Packaging for NDA: 209485
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 209485 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-151 | 68180-151-06 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-06) |
| MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 209485 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-151 | 68180-151-09 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-151-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 25MG | ||||
| Approval Date: | Sep 28, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 50MG | ||||
| Approval Date: | Sep 28, 2022 | TE: | AB | RLD: | No | ||||
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