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 ACTAVIS LABS FL INC
Abbreviated New Drug Application (ANDA): 071611
Company: ACTAVIS LABS FL 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 |
|---|---|---|---|---|---|---|---|
| 02/29/1988 | 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 |
|---|---|---|---|---|---|
| 07/30/2013 | SUPPL-70 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/11/2013 | SUPPL-69 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/24/2012 | SUPPL-67 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/03/2006 | SUPPL-40 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 02/03/2006 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 02/03/2006 | SUPPL-38 | Manufacturing (CMC)-New Strength |
Label is not available on this site. |
||
| 04/25/2001 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/29/2000 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/23/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1996 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1996 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1996 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1996 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1996 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/1996 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/1993 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 03/12/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/12/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1992 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/28/1991 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1991 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/1990 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1991 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1991 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1991 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/23/1991 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/20/1989 | 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 |
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