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
CLONAZEPAM از شرکت ACTAVIS ELIZABETH
Abbreviated New Drug Application (ANDA): 074869
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CLONAZEPAM | CLONAZEPAM | 2MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/31/1996 | 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 |
|---|---|---|---|---|---|
| 04/03/2013 | SUPPL-29 | REMS, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2011 | SUPPL-27 | REMS-Proposal, Labeling |
Label is not available on this site. |
||
| 10/15/2009 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/05/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/27/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/25/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/24/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/10/1997 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 05/23/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
CLONAZEPAM
TABLET;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077147 | ACCORD HLTHCARE |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074869 | ACTAVIS ELIZABETH |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077856 | PRINSTON INC |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074979 | SANDOZ |
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | No | AB | 074569 | TEVA |
| KLONOPIN | CLONAZEPAM | 0.5MG | TABLET;ORAL | Prescription | Yes | AB | 017533 | ROCHE |
TABLET;ORAL; 1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 077147 | ACCORD HLTHCARE |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074869 | ACTAVIS ELIZABETH |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 077856 | PRINSTON INC |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074979 | SANDOZ |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | No | AB | 074569 | TEVA |
| KLONOPIN | CLONAZEPAM | 1MG | TABLET;ORAL | Prescription | Yes | AB | 017533 | ROCHE |
TABLET;ORAL; 2MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 077147 | ACCORD HLTHCARE |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074869 | ACTAVIS ELIZABETH |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 077856 | PRINSTON INC |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074979 | SANDOZ |
| CLONAZEPAM | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | No | AB | 074569 | TEVA |
| KLONOPIN | CLONAZEPAM | 2MG | TABLET;ORAL | Prescription | Yes | AB | 017533 | ROCHE |
نظرات کاربران