0093-1921-06 |
0093-1921 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20190304 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021777 |
Teva Pharmaceuticals USA, Inc. |
CYCLOBENZAPRINE HYDROCHLORIDE |
30 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-1921-06) |
72189-362-60 |
72189-362 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine HCL ER |
Cyclobenzaprine HCL ER |
CAPSULE, EXTENDED RELEASE |
ORAL |
20220725 |
N/A |
NDA |
NDA021777 |
Direct_Rx |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-362-60) |
72189-389-60 |
72189-389 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine HCL ER |
Cyclobenzaprine HCL ER |
CAPSULE, EXTENDED RELEASE |
ORAL |
20221109 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021777 |
Direct_Rx |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72189-389-60) |
80425-0292-2 |
80425-0292 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine HCL ER |
Cyclobenzaprine HCL |
CAPSULE, EXTENDED RELEASE |
ORAL |
20230331 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021777 |
Advanced Rx Pharmacy of Tennessee, LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-2) |
80425-0292-3 |
80425-0292 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine HCL ER |
Cyclobenzaprine HCL |
CAPSULE, EXTENDED RELEASE |
ORAL |
20230331 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021777 |
Advanced Rx Pharmacy of Tennessee, LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-3) |
63459-701-60 |
63459-701 |
HUMAN PRESCRIPTION DRUG |
AMRIX |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20071101 |
N/A |
NDA |
NDA021777 |
Cephalon, LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
30 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63459-701-60) |
63459-700-60 |
63459-700 |
HUMAN PRESCRIPTION DRUG |
AMRIX |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20071002 |
N/A |
NDA |
NDA021777 |
Cephalon, LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63459-700-60) |
80425-0292-1 |
80425-0292 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine HCL ER |
Cyclobenzaprine HCL |
CAPSULE, EXTENDED RELEASE |
ORAL |
20230331 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021777 |
Advanced Rx Pharmacy of Tennessee, LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0292-1) |
0093-1920-06 |
0093-1920 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20190304 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021777 |
Teva Pharmaceuticals USA, Inc. |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-1920-06) |
0115-1436-13 |
0115-1436 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20190301 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021777 |
Amneal Pharmaceuticals of New York LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1436-13) |
0115-1437-13 |
0115-1437 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20190301 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021777 |
Amneal Pharmaceuticals of New York LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
30 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1437-13) |
55700-981-60 |
55700-981 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20220809 |
N/A |
NDA AUTHORIZED GENERIC |
NDA021777 |
Quality Care Products, LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55700-981-60) |