اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CYCLOBENZAPRINE HYDROCHLORIDE از شرکت MYLAN PHARMS INC
Abbreviated New Drug Application (ANDA): 073144
Company: MYLAN PHARMS INC
| 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 |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/31/1991 | 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-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/22/2005 | SUPPL-15 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 07/22/2005 | SUPPL-14 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 07/22/2005 | SUPPL-13 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 07/22/2005 | SUPPL-12 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 07/22/2005 | SUPPL-11 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 02/03/2006 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 07/22/2005 | SUPPL-9 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 06/28/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1993 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/07/1993 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 09/07/1993 | 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 | 078218 | ALEMBIC LABS |
| 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 | 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 | 073144 | MYLAN PHARMS INC |
| 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 | 078218 | ALEMBIC LABS |
| 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 | 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 | 073144 | MYLAN PHARMS INC |
| 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 |
TABLET;ORAL; 7.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 071611 | ACTAVIS LABS FL INC |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 078218 | ALEMBIC LABS |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 077563 | JUBILANT CADISTA |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 073144 | MYLAN PHARMS INC |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 208170 | RUBICON |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 078722 | SUN PHARM INDS LTD |
| CYCLOBENZAPRINE HYDROCHLORIDE | CYCLOBENZAPRINE HYDROCHLORIDE | 7.5MG | TABLET;ORAL | Prescription | No | AB | 213324 | UNICHEM |
منبع : www.accessdata.fda.gov
نظرات کاربران