Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075103
Company: ALPHARMA US PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CODAMINE HYDROCODONE BITARTRATE; PHENYLPROPANOLAMINE HYDROCHLORIDE 5MG/5ML;25MG/5ML SYRUP;ORAL Discontinued 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
09/29/2000 ORIG-1 Approval Letter (PDF)

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https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75103ltr.pdf

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