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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205120
Company: ALVOGEN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
10/30/2015 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205120Orig1s000ltr.pdf

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 ALVOGEN
BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL 325MG;50MG TABLET;ORAL Prescription No AA 203484 LARKEN LABS INC
BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL 325MG;50MG TABLET;ORAL Prescription No AA 214088 RISE PHARMA
BUTAPAP ACETAMINOPHEN; BUTALBITAL 325MG;50MG TABLET;ORAL Prescription No AA 089987 MIKART
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