| 71205-981-60 |
71205-981 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20200507 |
N/A |
ANDA |
ANDA209587 |
Proficient Rx LP |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
60 TABLET in 1 BOTTLE (71205-981-60) |
| 71205-981-72 |
71205-981 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20200507 |
N/A |
ANDA |
ANDA209587 |
Proficient Rx LP |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
120 TABLET in 1 BOTTLE (71205-981-72) |
| 71205-981-90 |
71205-981 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20200507 |
N/A |
ANDA |
ANDA209587 |
Proficient Rx LP |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
90 TABLET in 1 BOTTLE (71205-981-90) |
| 70518-4309-0 |
70518-4309 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20250314 |
N/A |
ANDA |
ANDA209587 |
REMEDYREPACK INC. |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
100 TABLET in 1 BOTTLE, PLASTIC (70518-4309-0) |
| 70518-4309-1 |
70518-4309 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20250804 |
N/A |
ANDA |
ANDA209587 |
REMEDYREPACK INC. |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
60 TABLET in 1 BOTTLE, PLASTIC (70518-4309-1) |
| 68788-8137-2 |
68788-8137 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20220211 |
N/A |
ANDA |
ANDA209587 |
Preferred Pharmaceuticals Inc. |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
20 TABLET in 1 BOTTLE (68788-8137-2) |
| 68788-8137-3 |
68788-8137 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20220211 |
N/A |
ANDA |
ANDA209587 |
Preferred Pharmaceuticals Inc. |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
30 TABLET in 1 BOTTLE (68788-8137-3) |
| 50268-553-13 |
50268-553 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20220811 |
N/A |
ANDA |
ANDA209587 |
AvPAK |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
30 BLISTER PACK in 1 BOX (50268-553-13) / 1 TABLET in 1 BLISTER PACK (50268-553-11) |
| 69367-203-01 |
69367-203 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20190305 |
N/A |
ANDA |
ANDA209587 |
Westminster Pharmaceuticals, LLC |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
100 TABLET in 1 BOTTLE (69367-203-01) |
| 69367-203-05 |
69367-203 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20190305 |
N/A |
ANDA |
ANDA209587 |
Westminster Pharmaceuticals, LLC |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
500 TABLET in 1 BOTTLE (69367-203-05) |
| 80425-0570-1 |
80425-0570 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20260108 |
N/A |
ANDA |
ANDA209587 |
Advanced Rx of Tennessee, LLC |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
30 TABLET in 1 BOTTLE (80425-0570-1) |
| 80425-0570-2 |
80425-0570 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20260108 |
N/A |
ANDA |
ANDA209587 |
Advanced Rx of Tennessee, LLC |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
60 TABLET in 1 BOTTLE (80425-0570-2) |
| 80425-0570-3 |
80425-0570 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20260108 |
N/A |
ANDA |
ANDA209587 |
Advanced Rx of Tennessee, LLC |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
90 TABLET in 1 BOTTLE (80425-0570-3) |
| 79739-7320-1 |
79739-7320 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20181101 |
N/A |
ANDA |
ANDA209587 |
LGM PHARMA SOLUTIONS, LLC |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
100 TABLET in 1 BOTTLE (79739-7320-1) |
| 79739-7320-5 |
79739-7320 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20181215 |
N/A |
ANDA |
ANDA209587 |
LGM PHARMA SOLUTIONS, LLC |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
500 TABLET in 1 BOTTLE (79739-7320-5) |