| 76420-895-01 |
76420-895 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20250107 |
N/A |
ANDA |
ANDA091281 |
Asclemed USA, Inc. |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-895-01) |
| 76420-895-30 |
76420-895 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20250107 |
N/A |
ANDA |
ANDA091281 |
Asclemed USA, Inc. |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-895-30) |
| 76420-895-60 |
76420-895 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20250107 |
N/A |
ANDA |
ANDA091281 |
Asclemed USA, Inc. |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-895-60) |
| 76420-895-90 |
76420-895 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20250107 |
N/A |
ANDA |
ANDA091281 |
Asclemed USA, Inc. |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-895-90) |
| 85509-1035-3 |
85509-1035 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20260119 |
N/A |
ANDA |
ANDA091281 |
PHOENIX RX LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-3) |
| 85509-1035-6 |
85509-1035 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20260119 |
N/A |
ANDA |
ANDA091281 |
PHOENIX RX LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-6) |
| 85509-1035-9 |
85509-1035 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20260119 |
N/A |
ANDA |
ANDA091281 |
PHOENIX RX LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (85509-1035-9) |
| 24979-035-04 |
24979-035 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20190301 |
N/A |
ANDA |
ANDA091281 |
Upsher-Smith Laboratories, LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-035-04) |
| 71335-2514-1 |
71335-2514 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20241024 |
N/A |
ANDA |
ANDA091281 |
Bryant Ranch Prepack |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2514-1) |
| 71335-2514-2 |
71335-2514 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20241024 |
N/A |
ANDA |
ANDA091281 |
Bryant Ranch Prepack |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2514-2) |
| 71335-2514-3 |
71335-2514 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20241024 |
N/A |
ANDA |
ANDA091281 |
Bryant Ranch Prepack |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2514-3) |
| 76420-896-01 |
76420-896 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20250107 |
N/A |
ANDA |
ANDA091281 |
Asclemed USA, Inc. |
CYCLOBENZAPRINE HYDROCHLORIDE |
30 mg/1 |
100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-896-01) |
| 76420-896-30 |
76420-896 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20250107 |
N/A |
ANDA |
ANDA091281 |
Asclemed USA, Inc. |
CYCLOBENZAPRINE HYDROCHLORIDE |
30 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-896-30) |
| 76420-896-60 |
76420-896 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20250107 |
N/A |
ANDA |
ANDA091281 |
Asclemed USA, Inc. |
CYCLOBENZAPRINE HYDROCHLORIDE |
30 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-896-60) |
| 76420-896-90 |
76420-896 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20250107 |
N/A |
ANDA |
ANDA091281 |
Asclemed USA, Inc. |
CYCLOBENZAPRINE HYDROCHLORIDE |
30 mg/1 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-896-90) |
| 70518-4225-0 |
70518-4225 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20241031 |
N/A |
ANDA |
ANDA091281 |
REMEDYREPACK INC. |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4225-0) |
| 24979-036-04 |
24979-036 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20190301 |
N/A |
ANDA |
ANDA091281 |
Upsher-Smith Laboratories, LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
30 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (24979-036-04) |
| 80425-0460-1 |
80425-0460 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20241218 |
N/A |
ANDA |
ANDA091281 |
Advanced Rx of Tennessee, LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0460-1) |
| 80425-0460-2 |
80425-0460 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20241218 |
N/A |
ANDA |
ANDA091281 |
Advanced Rx of Tennessee, LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0460-2) |
| 80425-0460-3 |
80425-0460 |
HUMAN PRESCRIPTION DRUG |
Cyclobenzaprine Hydrochloride |
Cyclobenzaprine Hydrochloride |
CAPSULE, EXTENDED RELEASE |
ORAL |
20241218 |
N/A |
ANDA |
ANDA091281 |
Advanced Rx of Tennessee, LLC |
CYCLOBENZAPRINE HYDROCHLORIDE |
15 mg/1 |
90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0460-3) |