Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206615
Company: XSPIRE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300MG;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
08/04/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

BUTALBITAL, ACETAMINOPHEN AND CAFFEINE

CAPSULE;ORAL; 300MG;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 300MG;50MG;40MG CAPSULE;ORAL Prescription No AA 213321 GRANULES PHARMS
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300MG;50MG;40MG CAPSULE;ORAL Prescription No AA 212082 LANNETT CO INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300MG;50MG;40MG CAPSULE;ORAL Prescription No AA 040885 LGM PHARMA
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300MG;50MG;40MG CAPSULE;ORAL Prescription No AA 210817 MAYNE PHARMA INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300MG;50MG;40MG CAPSULE;ORAL Prescription No AA 207118 NUVO PHARMS INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300MG;50MG;40MG CAPSULE;ORAL Prescription No AA 213046 TARO PHARM INDS LTD
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE ACETAMINOPHEN; BUTALBITAL; CAFFEINE 300MG;50MG;40MG CAPSULE;ORAL Prescription No AA 206615 XSPIRE PHARMA

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