Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204733
Company: AUROLIFE PHARMA 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 CAPSULE;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
09/26/2018 ORIG-1 Approval

Label is not available on this site.

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

CAPSULE;ORAL; 325MG;50MG;40MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription No AA 204733 AUROLIFE PHARMA LLC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription No AA 212083 LANNETT CO INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription No AA 089007 MAYNE PHARMA INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 325MG;50MG;40MG CAPSULE;ORAL Prescription No AA 214087 SENORES PHARMS

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