CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE از شرکت HERITAGE PHARMA

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): 072053

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 25MG BASE;10MG 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-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.

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