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
CHLORDIAZEPOXIDE HYDROCHLORIDE از شرکت WATSON LABS
Abbreviated New Drug Application (ANDA): 086383
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE HYDROCHLORIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 09/08/1978 | 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 |
|---|---|---|---|---|---|
| 02/05/2021 | SUPPL-37 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-36 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/03/1998 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/03/1998 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/05/1997 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1997 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/26/1997 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/22/1993 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 08/15/1988 | SUPPL-26 | Bioequivalence |
Label is not available on this site. |
||
| 08/22/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1988 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1988 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/1988 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1986 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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