Details for New Drug Application (NDA): 209485
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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 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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