Suppliers and packages for tradename: MIRABEGRON
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MIRABEGRON
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Lupin Ltd | MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 209485 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-151-06 | 1 BOTTLE in 1 CARTON (68180-151-06) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 2024-04-19 |
| Lupin Ltd | MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 209485 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-151-09 | 1 BOTTLE in 1 CARTON (68180-151-09) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 2024-04-19 |
| Lupin Ltd | MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 209485 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-152-06 | 1 BOTTLE in 1 CARTON (68180-152-06) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 2024-09-03 |
| Lupin Ltd | MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 209485 | ANDA | Lupin Pharmaceuticals, Inc. | 68180-152-09 | 1 BOTTLE in 1 CARTON (68180-152-09) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 2024-09-03 |
| Zydus Pharms | MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 209488 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1159-1 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1159-1) | 2024-01-23 |
| Zydus Pharms | MIRABEGRON | mirabegron | TABLET, EXTENDED RELEASE;ORAL | 209488 | ANDA | Zydus Pharmaceuticals (USA) Inc. | 70710-1159-3 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70710-1159-3) | 2024-01-23 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
