Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085363
Company: KV PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 325MG;45MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
08/23/1977 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/26/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/22/1991 SUPPL-18 Labeling

Label is not available on this site.

09/12/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

03/10/1989 SUPPL-16 Labeling

Label is not available on this site.

05/04/1988 SUPPL-15 Labeling

Label is not available on this site.

01/24/1984 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/07/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/07/1983 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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