Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088628
Company: TEVA
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 Prescription AA 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
03/06/1985 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
08/29/2017 SUPPL-67 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-66 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-65 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-63 Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-62 Labeling-Package Insert

Label is not available on this site.

06/22/2011 SUPPL-58 Labeling-Package Insert

Label is not available on this site.

07/18/2008 SUPPL-53 Labeling

Label is not available on this site.

01/07/2008 SUPPL-52 Labeling

Label is not available on this site.

07/07/2000 SUPPL-47 Manufacturing (CMC)-Facility

Label is not available on this site.

03/03/1999 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

10/27/1997 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

05/06/1997 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

11/27/1996 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

10/20/1995 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

01/27/1995 SUPPL-35 Labeling

Label is not available on this site.

03/02/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

09/22/1993 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/04/1993 SUPPL-26 Labeling

Label is not available on this site.

04/01/1993 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

08/04/1993 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/30/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/13/1992 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

07/29/1991 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/09/1989 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/11/1990 SUPPL-15 Labeling

Label is not available on this site.

11/09/1989 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/09/1989 SUPPL-12 Labeling

Label is not available on this site.

11/09/1989 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

04/08/1988 SUPPL-9 Labeling

Label is not available on this site.

11/01/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

ACETAMINOPHEN AND CODEINE PHOSPHATE

TABLET;ORAL; 300MG;30MG
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 040779 AMNEAL PHARMS NY
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 202800 AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 040419 MALLINCKRODT INC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 085868 SUN PHARM INDS LTD
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 088628 TEVA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 089805 VINTAGE
TYLENOL W/ CODEINE NO. 3 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;30MG TABLET;ORAL Prescription No AA 085055 JANSSEN PHARMS

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