BUTALBITAL, ACETAMINOPHEN AND CAFFEINE از شرکت SPECGX LLC

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 SPECGX LLC

Abbreviated New Drug Application (ANDA): 087804

Company: SPECGX LLC

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
01/24/1985 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
10/18/2013 SUPPL-39 Labeling-Package Insert

Label is not available on this site.

01/20/2012 SUPPL-38 Labeling-Package Insert

Label is not available on this site.

10/10/2006 SUPPL-34 Labeling

Label is not available on this site.

10/21/2002 SUPPL-30 Labeling

Label is not available on this site.

08/26/2002 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/2002 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/26/2000 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

08/19/1998 SUPPL-26 Labeling

Label is not available on this site.

11/23/1998 SUPPL-25 Labeling

Label is not available on this site.

11/23/1998 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/29/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

06/13/1994 SUPPL-20 Labeling

Label is not available on this site.

03/16/1994 SUPPL-19 Labeling

Label is not available on this site.

05/27/1993 SUPPL-18 Labeling

Label is not available on this site.

07/16/1992 SUPPL-16 Labeling

Label is not available on this site.

11/21/1989 SUPPL-12 Labeling

Label is not available on this site.

08/24/1988 SUPPL-11 Labeling

Label is not available on this site.

09/03/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/18/1988 SUPPL-9 Labeling

Label is not available on this site.

06/20/1996 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

09/03/1992 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

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