64950-205-03 |
64950-205 |
HUMAN PRESCRIPTION DRUG |
Hycodan |
Hydrocodone Bitartrate and Homatropine Methylbromide |
TABLET |
ORAL |
20211101 |
N/A |
NDA |
NDA005213 |
Genus Lifesciences Inc. |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
1.5 mg/1; 5 mg/1 |
30 TABLET in 1 BOTTLE, PLASTIC (64950-205-03) |
64950-205-10 |
64950-205 |
HUMAN PRESCRIPTION DRUG |
Hycodan |
Hydrocodone Bitartrate and Homatropine Methylbromide |
TABLET |
ORAL |
20211101 |
N/A |
NDA |
NDA005213 |
Genus Lifesciences Inc. |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
1.5 mg/1; 5 mg/1 |
100 TABLET in 1 BOTTLE, PLASTIC (64950-205-10) |
64950-342-45 |
64950-342 |
HUMAN PRESCRIPTION DRUG |
Hycodan |
Hydrocodone Bitartrate and Homatropine Methylbromide |
SOLUTION |
ORAL |
20191216 |
N/A |
NDA |
NDA005213 |
Genus Lifesciences Inc. |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
1.5 mg/5mL; 5 mg/5mL |
40 CUP, UNIT-DOSE in 1 CASE (64950-342-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-342-05) |
64950-342-47 |
64950-342 |
HUMAN PRESCRIPTION DRUG |
Hycodan |
Hydrocodone Bitartrate and Homatropine Methylbromide |
SOLUTION |
ORAL |
20190614 |
N/A |
NDA |
NDA005213 |
Genus Lifesciences Inc. |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
1.5 mg/5mL; 5 mg/5mL |
473 mL in 1 BOTTLE (64950-342-47) |
64950-371-47 |
64950-371 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Homatropine Methylbromide |
Hydrocodone Bitartrate and Homatropine Methylbromide |
SOLUTION |
ORAL |
20220810 |
N/A |
NDA AUTHORIZED GENERIC |
NDA005213 |
Genus Lifesciences Inc. |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
1.5 mg/5mL; 5 mg/5mL |
473 mL in 1 BOTTLE (64950-371-47) |
64950-206-03 |
64950-206 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Homatropine Methylbromide |
Hydrocodone Bitartrate and Homatropine Methylbromide |
TABLET |
ORAL |
20220810 |
N/A |
NDA AUTHORIZED GENERIC |
NDA005213 |
Genus Lifesciences Inc. |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
1.5 mg/1; 5 mg/1 |
30 TABLET in 1 BOTTLE, PLASTIC (64950-206-03) |
64950-206-10 |
64950-206 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Homatropine Methylbromide |
Hydrocodone Bitartrate and Homatropine Methylbromide |
TABLET |
ORAL |
20220810 |
N/A |
NDA AUTHORIZED GENERIC |
NDA005213 |
Genus Lifesciences Inc. |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
1.5 mg/1; 5 mg/1 |
100 TABLET in 1 BOTTLE, PLASTIC (64950-206-10) |
0121-1036-40 |
0121-1036 |
HUMAN PRESCRIPTION DRUG |
Hydrocodone Bitartrate and Homatropine Methylbromide |
Hydrocodone Bitartrate and Homatropine Methylbromide |
SOLUTION |
ORAL |
20240805 |
N/A |
NDA AUTHORIZED GENERIC |
NDA005213 |
PAI Holdings, LLC dba PAI Pharma |
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE |
1.5 mg/5mL; 5 mg/5mL |
4 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05) |