Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086681
Company: PUREPAC PHARM
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
05/11/1979 ORIG-1 Approval Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/pre96/086681_acetaminophen_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/02/2001 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/2001 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

04/07/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/18/1996 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

09/29/1994 SUPPL-28 Labeling

Label is not available on this site.

09/08/1993 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/26/1991 SUPPL-25 Labeling

Label is not available on this site.

11/15/1990 SUPPL-24 Labeling

Label is not available on this site.

06/29/1989 SUPPL-23 Labeling

Label is not available on this site.

07/03/1991 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/03/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/10/1989 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/22/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/14/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/12/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/18/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/18/1984 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/18/1984 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/18/1984 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

12/06/1982 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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