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, Ascent Pharms Inc, Lupin Ltd, MSN, Qilu, Sawai Usa, and Zydus Pharms, and is included in nine NDAs. It is available from six 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. Eight 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. Eight suppliers are listed for this compound. Additional details are available on the mirabegron profile page.
Summary for 209485
| Tradename: | MIRABEGRON |
| Applicant: | Lupin Ltd |
| 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 | 1 BOTTLE in 1 CARTON (68180-151-06) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
| MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 209485 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-151 | 68180-151-09 | 1 BOTTLE in 1 CARTON (68180-151-09) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
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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