Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203484
Company: LARKEN LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALLZITAL ACETAMINOPHEN; BUTALBITAL 325MG;25MG TABLET;ORAL Prescription None No No
BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL 325MG;50MG TABLET;ORAL Prescription AA 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
12/04/2015 ORIG-1 Approval

Label is not available on this site.

ALLZITAL

There are no Therapeutic Equivalents.

BUTALBITAL AND ACETAMINOPHEN

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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