Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040098
Company: DAVA PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 120MG/5ML;12MG/5ML SOLUTION;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
09/20/1996 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40098_Acetaminophen%20And%20Codeine%20Phosphate_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40098_Acetaminophen%20And%20Codeine%20Phosphate_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/040098_acetaminophen_TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/27/2001 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/20/1996 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/40098_Acetaminophen%20And%20Codeine%20Phosphate_Prntlbl.pdf

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