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 AND AMITRIPTYLINE HYDROCHLORIDE از شرکت FRONTIDA BIOPHARM
Abbreviated New Drug Application (ANDA): 070765
Company: FRONTIDA BIOPHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE | AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE | EQ 12.5MG BASE;5MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 12/10/1986 | 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-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/01/2017 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/25/2016 | SUPPL-22 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/11/2014 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1995 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1993 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1995 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 01/11/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/26/1989 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/08/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/30/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/11/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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