BUTALBITAL, ACETAMINOPHEN AND CAFFEINE از شرکت HIKMA PHARMS

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 HIKMA PHARMS

Abbreviated New Drug Application (ANDA): 089718

Company: HIKMA PHARMS

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
06/12/1995 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
06/01/2016 SUPPL-17 Labeling-Container/Carton Labels

Label is not available on this site.

10/18/2013 SUPPL-15 Labeling

Label is not available on this site.

06/23/2011 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

06/03/2003 SUPPL-8 Labeling

Label is not available on this site.

08/23/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/18/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

03/25/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/27/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/08/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/27/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

بخوانید  BUTALBITAL, ACETAMINOPHEN AND CAFFEINE از شرکت LANNETT CO INC
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