Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040098
Company: DAVA PHARMS INC

Products on ANDA 040098

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040098

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.

Labels for ANDA 040098

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