Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089987
Company: MIKART
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTAPAP ACETAMINOPHEN; BUTALBITAL 325MG;50MG TABLET;ORAL Prescription AA No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/26/1992 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-15 Labeling-Package Insert

Label is not available on this site.

06/22/2011 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

08/13/2002 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

03/28/2001 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/2001 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/25/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/31/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

07/24/2000 SUPPL-5 Labeling

Label is not available on this site.

08/13/1996 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/08/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/08/1994 SUPPL-1 Labeling

Label is not available on this site.

BUTAPAP

TABLET;ORAL; 325MG;50MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL 325MG;50MG TABLET;ORAL Prescription No AA 205120 CNTY LINE PHARMS
BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL 325MG;50MG TABLET;ORAL Prescription No AA 203484 LARKEN LABS INC
BUTAPAP ACETAMINOPHEN; BUTALBITAL 325MG;50MG TABLET;ORAL Prescription No AA 089987 MIKART

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