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 BARR
Abbreviated New Drug Application (ANDA): 084768
Company: BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE HYDROCHLORIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | 5MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 06/10/1976 | 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-93 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-89 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/04/2001 | SUPPL-85 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/23/2000 | SUPPL-84 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 06/23/2000 | SUPPL-83 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/21/1999 | SUPPL-81 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/13/1999 | SUPPL-80 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-79 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/16/1998 | SUPPL-78 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-77 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1997 | SUPPL-76 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-75 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/02/1993 | SUPPL-74 | Labeling |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-73 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1992 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1989 | SUPPL-69 | Labeling |
Label is not available on this site. |
||
| 07/17/1987 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/17/1987 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/1987 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1985 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1985 | SUPPL-59 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1985 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1985 | SUPPL-57 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/07/1982 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE HYDROCHLORIDE | CHLORDIAZEPOXIDE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 084768 | BARR |
| LIBRIUM | CHLORDIAZEPOXIDE HYDROCHLORIDE | 5MG | CAPSULE;ORAL | Prescription | No | AB | 085461 | VALEANT PHARM INTL |
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