| 69292-303-01 |
69292-303 |
HUMAN PRESCRIPTION DRUG |
BUTALBITAL AND ACETAMINOPHEN |
butalbital and acetaminophen |
TABLET |
ORAL |
20260315 |
N/A |
ANDA |
ANDA214088 |
Amici Pharma, Inc. |
ACETAMINOPHEN; BUTALBITAL |
325 mg/1; 25 mg/1 |
100 TABLET in 1 BOTTLE (69292-303-01) |
| 69292-302-01 |
69292-302 |
HUMAN PRESCRIPTION DRUG |
BUTALBITAL AND ACETAMINOPHEN |
butalbital and acetaminophen |
TABLET |
ORAL |
20260315 |
N/A |
ANDA |
ANDA214088 |
Amici Pharma, Inc. |
ACETAMINOPHEN; BUTALBITAL |
325 mg/1; 50 mg/1 |
100 TABLET in 1 BOTTLE (69292-302-01) |
| 69292-301-01 |
69292-301 |
HUMAN PRESCRIPTION DRUG |
BUTALBITAL AND ACETAMINOPHEN |
butalbital and acetaminophen |
TABLET |
ORAL |
20260315 |
N/A |
ANDA |
ANDA214088 |
Amici Pharma, Inc. |
ACETAMINOPHEN; BUTALBITAL |
300 mg/1; 50 mg/1 |
100 TABLET in 1 BOTTLE (69292-301-01) |
| 35573-456-02 |
35573-456 |
HUMAN PRESCRIPTION DRUG |
BUTALBITAL AND ACETAMINOPHEN |
butalbital and acetaminophen |
TABLET |
ORAL |
20221201 |
N/A |
ANDA |
ANDA214088 |
Burel Pharmaceuticals, LLC |
ACETAMINOPHEN; BUTALBITAL |
325 mg/1; 50 mg/1 |
100 TABLET in 1 BOTTLE (35573-456-02) |
| 35573-455-02 |
35573-455 |
HUMAN PRESCRIPTION DRUG |
BUTALBITAL AND ACETAMINOPHEN |
butalbital and acetaminophen |
TABLET |
ORAL |
20221201 |
N/A |
ANDA |
ANDA214088 |
Burel Pharmaceuticals, LLC |
ACETAMINOPHEN; BUTALBITAL |
300 mg/1; 50 mg/1 |
100 TABLET in 1 BOTTLE (35573-455-02) |