Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088629
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription AA No Yes
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-66 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-65 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-64 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-61 Labeling-Package Insert

Label is not available on this site.

05/10/2013 SUPPL-60 Labeling-Package Insert

Label is not available on this site.

06/22/2011 SUPPL-57 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-46 Manufacturing (CMC)-Facility

Label is not available on this site.

03/03/1999 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

12/31/1998 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

03/09/1998 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

12/16/1997 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

05/06/1997 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/27/1996 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

08/16/1996 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/28/1995 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.

10/03/1995 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/03/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

10/20/1995 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

01/27/1995 SUPPL-32 Labeling

Label is not available on this site.

04/28/1995 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/10/1995 SUPPL-30 Labeling

Label is not available on this site.

03/02/1995 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.

01/26/1994 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

01/26/1994 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/26/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/10/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/22/1993 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/10/1995 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

03/10/1995 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/04/1993 SUPPL-18 Labeling

Label is not available on this site.

04/01/1993 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

05/25/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/01/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

01/11/1990 SUPPL-10 Labeling

Label is not available on this site.

04/08/1988 SUPPL-8 Labeling

Label is not available on this site.

10/10/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

10/10/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

10/10/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

ACETAMINOPHEN AND CODEINE PHOSPHATE

TABLET;ORAL; 300MG;60MG
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;60MG TABLET;ORAL Prescription No AA 202800 AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 040419 MALLINCKRODT INC
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 087083 SUN PHARM INDS LTD
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 088629 TEVA
ACETAMINOPHEN AND CODEINE PHOSPHATE ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 089828 VINTAGE PHARMS
TYLENOL W/ CODEINE NO. 4 ACETAMINOPHEN; CODEINE PHOSPHATE 300MG;60MG TABLET;ORAL Prescription No AA 085055 JANSSEN PHARMS

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