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 HERITAGE PHARMA
Abbreviated New Drug Application (ANDA): 072052
Company: HERITAGE PHARMA
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 |
---|---|---|---|---|---|---|---|
12/16/1988 | 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-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/16/2016 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
04/25/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
12/22/2014 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
12/08/1995 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
11/24/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
01/28/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/31/1991 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/29/1990 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/25/1989 | SUPPL-1 | Labeling |
Label is not available on this site. |
حتما بخوانید : ALENDRONATE SODIUM از شرکت IMPAX LABS INC
منبع : www.accessdata.fda.gov
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