| 64950-373-16 |
64950-373 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Acetaminophen |
hydrocodone bitartrate and acetaminophen |
SOLUTION |
ORAL |
20231015 |
N/A |
ANDA |
ANDA040838 |
Genus Lifesciences Inc. |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
325 mg/15mL; 7.5 mg/15mL |
473 mL in 1 BOTTLE (64950-373-16) |
| 67296-1476-7 |
67296-1476 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Acetaminophen |
HYDROCODONE BITARTRATE and ACETAMINOPHEN |
SOLUTION |
ORAL |
20130729 |
N/A |
ANDA |
ANDA040838 |
Redpharm Drug, Inc |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
325 mg/15mL; 7.5 mg/15mL |
118 mL in 1 BOTTLE (67296-1476-7) |
| 0121-0772-16 |
0121-0772 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Acetaminophen |
HYDROCODONE BITARTRATE and ACETAMINOPHEN |
SOLUTION |
ORAL |
20130729 |
N/A |
ANDA |
ANDA040838 |
PAI Holdings, LLC |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
325 mg/15mL; 7.5 mg/15mL |
473 mL in 1 BOTTLE (0121-0772-16) |
| 0121-0772-04 |
0121-0772 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Acetaminophen |
HYDROCODONE BITARTRATE and ACETAMINOPHEN |
SOLUTION |
ORAL |
20130729 |
N/A |
ANDA |
ANDA040838 |
PAI Holdings, LLC |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
325 mg/15mL; 7.5 mg/15mL |
118 mL in 1 BOTTLE (0121-0772-04) |
| 67296-2093-1 |
67296-2093 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Acetaminophen |
hydrocodone bitartrate and acetaminophen |
SOLUTION |
ORAL |
20231015 |
N/A |
ANDA |
ANDA040838 |
Redpharm drug |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
325 mg/15mL; 7.5 mg/15mL |
118 mL in 1 BOTTLE (67296-2093-1) |
| 0121-1544-40 |
0121-1544 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Acetaminophen |
HYDROCODONE BITARTRATE and ACETAMINOPHEN |
SOLUTION |
ORAL |
20130729 |
N/A |
ANDA |
ANDA040838 |
PAI Holdings, LLC |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
217 mg/10mL; 5 mg/10mL |
4 TRAY in 1 CASE (0121-1544-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1544-10) |
| 0121-2316-40 |
0121-2316 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Acetaminophen |
HYDROCODONE BITARTRATE and ACETAMINOPHEN |
SOLUTION |
ORAL |
20130729 |
N/A |
ANDA |
ANDA040838 |
PAI Holdings, LLC |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
325 mg/15mL; 7.5 mg/15mL |
4 TRAY in 1 CASE (0121-2316-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE (0121-2316-15) |
| 0121-2316-50 |
0121-2316 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Acetaminophen |
HYDROCODONE BITARTRATE and ACETAMINOPHEN |
SOLUTION |
ORAL |
20200521 |
N/A |
ANDA |
ANDA040838 |
PAI Holdings, LLC |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
325 mg/15mL; 7.5 mg/15mL |
5 TRAY in 1 CASE (0121-2316-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE |
| 0121-4772-15 |
0121-4772 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Acetaminophen |
HYDROCODONE BITARTRATE and ACETAMINOPHEN |
SOLUTION |
ORAL |
20130729 |
N/A |
ANDA |
ANDA040838 |
PAI Holdings, LLC |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
108 mg/5mL; 2.5 mg/5mL |
4 TRAY in 1 CASE (0121-4772-15) / 10 CUP, UNIT-DOSE in 1 TRAY / 15 mL in 1 CUP, UNIT-DOSE |
| 0121-4772-40 |
0121-4772 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Acetaminophen |
HYDROCODONE BITARTRATE and ACETAMINOPHEN |
SOLUTION |
ORAL |
20130729 |
N/A |
ANDA |
ANDA040838 |
PAI Holdings, LLC |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
108 mg/5mL; 2.5 mg/5mL |
4 TRAY in 1 CASE (0121-4772-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4772-05) |
| 0121-4772-10 |
0121-4772 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Acetaminophen |
HYDROCODONE BITARTRATE and ACETAMINOPHEN |
SOLUTION |
ORAL |
20130729 |
N/A |
ANDA |
ANDA040838 |
PAI Holdings, LLC |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
108 mg/5mL; 2.5 mg/5mL |
4 TRAY in 1 CASE (0121-4772-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE |