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 AUROLIFE PHARMA LLC
Abbreviated New Drug Application (ANDA): 071858
Company: AUROLIFE PHARMA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 15MG | TABLET;ORAL | Prescription |
AB |
No | Yes |
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 3.75MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CLORAZEPATE DIPOTASSIUM | CLORAZEPATE DIPOTASSIUM | 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 |
|---|---|---|---|---|---|---|---|
| 07/17/1987 | 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 |
|---|---|---|---|---|---|
| 10/27/2010 | SUPPL-20 | Labeling-Container/Carton Labels, Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |
||
| 01/14/2010 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/02/2004 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/01/2003 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 02/25/1998 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/17/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/11/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 01/31/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1987 | SUPPL-1 | Manufacturing (CMC) |
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; 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 |
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 |
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