BUTALBITAL, ACETAMINOPHEN AND CAFFEINE از شرکت WATSON LABS

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

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE از شرکت WATSON LABS

Abbreviated New Drug Application (ANDA): 089536

Company: WATSON LABS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG 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
02/16/1988 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
11/03/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

09/29/2003 SUPPL-24 Labeling

Label is not available on this site.

07/24/2002 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2002 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

05/03/2002 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

07/24/2002 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

09/24/2001 SUPPL-16 Manufacturing (CMC)-Facility

Label is not available on this site.

11/02/2001 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

08/08/2000 SUPPL-10 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

02/04/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/16/1994 SUPPL-8 Labeling

Label is not available on this site.

05/08/1992 SUPPL-7 Labeling

Label is not available on this site.

08/16/1991 SUPPL-6 Labeling

Label is not available on this site.

06/02/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

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