Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084656
Company: ROXANE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG 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
05/10/1976 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
12/28/2000 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

08/28/1996 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.

03/15/1995 SUPPL-48 Labeling

Label is not available on this site.

09/28/1994 SUPPL-47 Labeling

Label is not available on this site.

12/16/1993 SUPPL-46 Labeling

Label is not available on this site.

10/03/1990 SUPPL-43 Labeling

Label is not available on this site.

12/05/1989 SUPPL-42 Labeling

Label is not available on this site.

01/03/1989 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

03/01/1989 SUPPL-37 Labeling

Label is not available on this site.

04/06/1984 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

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