Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207313
Company: MAYNE PHARMA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL 300MG;50MG CAPSULE;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
12/27/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

BUTALBITAL AND ACETAMINOPHEN

CAPSULE;ORAL; 300MG;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 300MG;50MG CAPSULE;ORAL Prescription No AA 213115 GRANULES
BUTALBITAL AND ACETAMINOPHEN ACETAMINOPHEN; BUTALBITAL 300MG;50MG CAPSULE;ORAL Prescription No AA 207313 MAYNE PHARMA INC

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