Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 073541
Company: ANDA REPOSITORY
Company: ANDA REPOSITORY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | AB | No | No |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/23/1995 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/11/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/06/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 04/06/2006 | SUPPL-6 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 08/19/2005 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CYCLOBENZAPRINE HYDROCHLORIDE
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 071611 | ACTAVIS LABS FL INC |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 073541 | ANDA REPOSITORY |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078643 | AUROBINDO PHARMA |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078218 | CHARTWELL RX |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 090478 | INVAGEN PHARMS |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 077563 | JUBILANT CADISTA |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078048 | KVK TECH |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 077209 | OXFORD PHARMS |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 077797 | PRINSTON INC |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 208170 | RUBICON |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 078722 | SUN PHARM INDS LTD |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 213324 | UNICHEM |
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 071611 | ACTAVIS LABS FL INC |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 073541 | ANDA REPOSITORY |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078643 | AUROBINDO PHARMA |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078218 | CHARTWELL RX |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 090478 | INVAGEN PHARMS |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 077563 | JUBILANT CADISTA |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078048 | KVK TECH |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 077209 | OXFORD PHARMS |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 077797 | PRINSTON INC |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 208170 | RUBICON |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 078722 | SUN PHARM INDS LTD |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 213324 | UNICHEM |