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
CLORAZEPATE DIPOTASSIUM از شرکت TARO
Abbreviated New Drug Application (ANDA): 075731
Company: TARO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 3.75MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/27/2000 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75731ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/20/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/27/2011 | SUPPL-3 | Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
||
| 01/20/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
CLORAZEPATE DIPOTASSIUM
TABLET;ORAL; 15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET;ORAL | Prescription | No | AB | 071858 | AUROLIFE PHARMA LLC |
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET;ORAL | Prescription | No | AB | 075731 | TARO |
| GEN-XENE | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET;ORAL | Prescription | No | AB | 071789 | ALRA |
TABLET;ORAL; 7.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 071858 | AUROLIFE PHARMA LLC |
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 075731 | TARO |
| GEN-XENE | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | No | AB | 071788 | ALRA |
| TRANXENE | CLORAZEPATE DIPOTASSIUM | 7.5MG | TABLET;ORAL | Prescription | Yes | AB | 017105 | RECORDATI RARE |
TABLET;ORAL; 3.75MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET;ORAL | Prescription | No | AB | 071858 | AUROLIFE PHARMA LLC |
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET;ORAL | Prescription | No | AB | 075731 | TARO |
| GEN-XENE | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET;ORAL | Prescription | No | AB | 071787 | ALRA |
منبع : www.accessdata.fda.gov
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