| 71335-2809-1 |
71335-2809 |
HUMAN PRESCRIPTION DRUG |
MIRABEGRON |
mirabegron |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20250926 |
N/A |
ANDA |
ANDA209485 |
Bryant Ranch Prepack |
MIRABEGRON |
25 mg/1 |
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2809-1) |
| 71335-2810-1 |
71335-2810 |
HUMAN PRESCRIPTION DRUG |
MIRABEGRON |
mirabegron |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20250926 |
N/A |
ANDA |
ANDA209485 |
Bryant Ranch Prepack |
MIRABEGRON |
50 mg/1 |
90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-2810-1) |
| 68180-151-06 |
68180-151 |
HUMAN PRESCRIPTION DRUG |
MIRABEGRON |
mirabegron |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20240419 |
N/A |
ANDA |
ANDA209485 |
Lupin Pharmaceuticals, Inc. |
MIRABEGRON |
25 mg/1 |
1 BOTTLE in 1 CARTON (68180-151-06) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
| 68180-151-09 |
68180-151 |
HUMAN PRESCRIPTION DRUG |
MIRABEGRON |
mirabegron |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20240419 |
N/A |
ANDA |
ANDA209485 |
Lupin Pharmaceuticals, Inc. |
MIRABEGRON |
25 mg/1 |
1 BOTTLE in 1 CARTON (68180-151-09) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
| 71335-2808-1 |
71335-2808 |
HUMAN PRESCRIPTION DRUG |
MIRABEGRON |
mirabegron |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20250926 |
N/A |
ANDA |
ANDA209485 |
Bryant Ranch Prepack |
MIRABEGRON |
50 mg/1 |
1 BOTTLE in 1 CARTON (71335-2808-1) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
| 71335-2807-1 |
71335-2807 |
HUMAN PRESCRIPTION DRUG |
MIRABEGRON |
mirabegron |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20250926 |
N/A |
ANDA |
ANDA209485 |
Bryant Ranch Prepack |
MIRABEGRON |
25 mg/1 |
1 BOTTLE in 1 CARTON (71335-2807-1) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
| 68180-152-06 |
68180-152 |
HUMAN PRESCRIPTION DRUG |
MIRABEGRON |
mirabegron |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20240903 |
N/A |
ANDA |
ANDA209485 |
Lupin Pharmaceuticals, Inc. |
MIRABEGRON |
50 mg/1 |
1 BOTTLE in 1 CARTON (68180-152-06) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |
| 68180-152-09 |
68180-152 |
HUMAN PRESCRIPTION DRUG |
MIRABEGRON |
mirabegron |
TABLET, FILM COATED, EXTENDED RELEASE |
ORAL |
20240903 |
N/A |
ANDA |
ANDA209485 |
Lupin Pharmaceuticals, Inc. |
MIRABEGRON |
50 mg/1 |
1 BOTTLE in 1 CARTON (68180-152-09) / 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE |