| 72189-441-12 |
72189-441 |
HUMAN PRESCRIPTION DRUG |
Butal/APAP/Caff |
Butal/APAP/Caff |
TABLET |
ORAL |
20230314 |
N/A |
ANDA |
ANDA200243 |
Direct_Rx |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
12 TABLET in 1 BOTTLE (72189-441-12) |
| 72189-441-30 |
72189-441 |
HUMAN PRESCRIPTION DRUG |
Butal/APAP/Caff |
Butal/APAP/Caff |
TABLET |
ORAL |
20230314 |
N/A |
ANDA |
ANDA200243 |
Direct_Rx |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
30 TABLET in 1 BOTTLE (72189-441-30) |
| 72189-441-60 |
72189-441 |
HUMAN PRESCRIPTION DRUG |
Butal/APAP/Caff |
Butal/APAP/Caff |
TABLET |
ORAL |
20230314 |
N/A |
ANDA |
ANDA200243 |
Direct_Rx |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
60 TABLET in 1 BOTTLE (72189-441-60) |
| 68071-3249-6 |
68071-3249 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20170505 |
N/A |
ANDA |
ANDA200243 |
NuCare Pharmaceuticals, Inc. |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
60 TABLET in 1 BOTTLE (68071-3249-6) |
| 68071-3249-3 |
68071-3249 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20170505 |
N/A |
ANDA |
ANDA200243 |
NuCare Pharmaceuticals, Inc. |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
30 TABLET in 1 BOTTLE (68071-3249-3) |
| 68071-3249-2 |
68071-3249 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20170505 |
N/A |
ANDA |
ANDA200243 |
NuCare Pharmaceuticals, Inc. |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
20 TABLET in 1 BOTTLE (68071-3249-2) |
| 68071-3249-0 |
68071-3249 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20170816 |
N/A |
ANDA |
ANDA200243 |
NuCare Pharmaceuticals, Inc. |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
10 TABLET in 1 BOTTLE (68071-3249-0) |
| 63187-933-14 |
63187-933 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20200228 |
N/A |
ANDA |
ANDA200243 |
Proficient Rx LP |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
14 TABLET in 1 BOTTLE, PLASTIC (63187-933-14) |
| 63187-933-30 |
63187-933 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20171101 |
N/A |
ANDA |
ANDA200243 |
Proficient Rx LP |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
30 TABLET in 1 BOTTLE, PLASTIC (63187-933-30) |
| 63187-933-60 |
63187-933 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20171101 |
N/A |
ANDA |
ANDA200243 |
Proficient Rx LP |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
60 TABLET in 1 BOTTLE, PLASTIC (63187-933-60) |
| 63187-933-90 |
63187-933 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20171101 |
N/A |
ANDA |
ANDA200243 |
Proficient Rx LP |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
90 TABLET in 1 BOTTLE, PLASTIC (63187-933-90) |
| 0904-6938-06 |
0904-6938 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20120913 |
N/A |
ANDA |
ANDA200243 |
Major Pharmaceuticals |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
50 BLISTER PACK in 1 CARTON (0904-6938-06) / 1 TABLET in 1 BLISTER PACK |
| 63629-8392-3 |
63629-8392 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20201209 |
N/A |
ANDA |
ANDA200243 |
Bryant Ranch Prepack |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
60 TABLET in 1 BOTTLE (63629-8392-3) |
| 63629-8392-4 |
63629-8392 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20210120 |
N/A |
ANDA |
ANDA200243 |
Bryant Ranch Prepack |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
90 TABLET in 1 BOTTLE (63629-8392-4) |
| 63629-8392-5 |
63629-8392 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20241029 |
N/A |
ANDA |
ANDA200243 |
Bryant Ranch Prepack |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
50 TABLET in 1 BOTTLE (63629-8392-5) |
| 63629-8392-6 |
63629-8392 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20241029 |
N/A |
ANDA |
ANDA200243 |
Bryant Ranch Prepack |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
6 TABLET in 1 BOTTLE (63629-8392-6) |
| 63629-8392-7 |
63629-8392 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20241029 |
N/A |
ANDA |
ANDA200243 |
Bryant Ranch Prepack |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
120 TABLET in 1 BOTTLE (63629-8392-7) |
| 63629-8392-8 |
63629-8392 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20241029 |
N/A |
ANDA |
ANDA200243 |
Bryant Ranch Prepack |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
40 TABLET in 1 BOTTLE (63629-8392-8) |
| 63629-8392-9 |
63629-8392 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20201208 |
N/A |
ANDA |
ANDA200243 |
Bryant Ranch Prepack |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
12 TABLET in 1 BOTTLE (63629-8392-9) |
| 63629-8392-0 |
63629-8392 |
HUMAN PRESCRIPTION DRUG |
Butalbital, Acetaminophen, and Caffeine |
Butalbital, Acetaminophen, and Caffeine |
TABLET |
ORAL |
20241029 |
N/A |
ANDA |
ANDA200243 |
Bryant Ranch Prepack |
ACETAMINOPHEN; BUTALBITAL; CAFFEINE |
325 mg/1; 50 mg/1; 40 mg/1 |
84 TABLET in 1 BOTTLE (63629-8392-0) |