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 SANDOZ
Abbreviated New Drug Application (ANDA): 074979
Company: SANDOZ
| 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 |
|---|---|---|---|---|---|---|---|
| 08/29/1997 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/74979ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/23/2018 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2017 | SUPPL-23 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/18/2016 | SUPPL-21 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/23/2012 | SUPPL-15 | Labeling-Medication Guide, REMS-Modified |
Label is not available on this site. |
||
| 03/30/2011 | SUPPL-14 | Labeling-Container/Carton Labels, REMS-Proposal, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/30/2011 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 02/23/2010 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2000 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/02/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
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 |
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