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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076528
Company: ABLE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE 325MG;50MG;40MG;30MG CAPSULE;ORAL Discontinued None No No
BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE 40MG/30MG Capsule; Oral Prescription None 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
08/21/2003 ORIG-1 Approval

Label is not available on this site.

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