Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 007073
Company: PHARMACIA AND UPJOHN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AZULFIDINE SULFASALAZINE 500MG TABLET;ORAL Prescription AB Yes Yes
AZULFIDINE EN-TABS SULFASALAZINE 500MG TABLET, DELAYED RELEASE;ORAL Prescription AB Yes 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
06/20/1950 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2014 SUPPL-128 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/007073s128lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/007073Orig1s128ltr.pdf
11/20/2015 SUPPL-127 Manufacturing (CMC)

Label is not available on this site.

07/18/2013 SUPPL-126 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007073s126lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/007073Orig1s126ltr.pdf
12/12/2012 SUPPL-125 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/007073s125lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/007073Orig1s125ltr.pdf
10/19/2009 SUPPL-124 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/007073s124lbl.pdf
11/12/2002 SUPPL-121 Manufacturing (CMC)

Label is not available on this site.

07/30/2002 SUPPL-120 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/7073slr120ltr.pdf
09/26/2000 SUPPL-118 Labeling

Label is not available on this site.

02/05/2001 SUPPL-117 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/18/2000 SUPPL-116 Labeling

Label is not available on this site.

08/17/2001 SUPPL-115 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/7073s115lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/07073s115ltr.pdf
04/18/2000 SUPPL-113 Labeling

Label is not available on this site.

04/25/2000 SUPPL-112 Labeling

Label is not available on this site.

08/13/1999 SUPPL-110 Labeling

Label is not available on this site.

04/24/2000 SUPPL-109 Labeling

Label is not available on this site.

12/23/1997 SUPPL-107 Manufacturing (CMC)

Label is not available on this site.

05/18/1995 SUPPL-106 Manufacturing (CMC)

Label is not available on this site.

07/25/1996 SUPPL-105 Manufacturing (CMC)

Label is not available on this site.

03/05/1996 SUPPL-104 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1996 SUPPL-103 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/17/1996 SUPPL-102 Labeling

Label is not available on this site.

06/14/1996 SUPPL-101 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/29/1995 SUPPL-100 Manufacturing (CMC)

Label is not available on this site.

02/21/1996 SUPPL-99 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/19/1994 SUPPL-98 Manufacturing (CMC)-Control

Label is not available on this site.

09/28/1995 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

11/03/1993 SUPPL-96 Labeling

Label is not available on this site.

11/02/1993 SUPPL-95 Labeling

Label is not available on this site.

10/20/1993 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

06/08/1994 SUPPL-93 Manufacturing (CMC)

Label is not available on this site.

06/08/1994 SUPPL-92 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/05/1993 SUPPL-91 Labeling

Label is not available on this site.

04/05/1993 SUPPL-90 Labeling

Label is not available on this site.

08/09/1993 SUPPL-89 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1993 SUPPL-88 Manufacturing (CMC)-Control

Label is not available on this site.

01/26/1994 SUPPL-87 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1993 SUPPL-86 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1994 SUPPL-85 Manufacturing (CMC)-Control

Label is not available on this site.

10/20/1993 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

09/22/1992 SUPPL-83 Manufacturing (CMC)-Control

Label is not available on this site.

11/07/1990 SUPPL-82 Labeling

Label is not available on this site.

11/07/1990 SUPPL-81 Labeling

Label is not available on this site.

07/10/1991 SUPPL-80 Manufacturing (CMC)-Formulation

Label is not available on this site.

07/10/1991 SUPPL-79 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/11/1984 SUPPL-77 Labeling

Label is not available on this site.

12/12/1983 SUPPL-76 Labeling

Label is not available on this site.

01/18/1983 SUPPL-75 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/19/1985 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

07/02/1982 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

07/15/1982 SUPPL-72 Manufacturing (CMC)

Label is not available on this site.

02/05/1985 SUPPL-71 Labeling

Label is not available on this site.

02/05/1985 SUPPL-70 Labeling

Label is not available on this site.

06/30/1981 SUPPL-65 Labeling

Label is not available on this site.

03/25/1981 SUPPL-64 Labeling

Label is not available on this site.

03/25/1981 SUPPL-61 Labeling

Label is not available on this site.

03/25/1981 SUPPL-60 Labeling

Label is not available on this site.

03/05/1981 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1983 SUPPL-20 Labeling

Label is not available on this site.

04/06/1983 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/06/1983 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/04/2014 SUPPL-128 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/007073s128lbl.pdf
07/18/2013 SUPPL-126 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/007073s126lbl.pdf
12/12/2012 SUPPL-125 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/007073s125lbl.pdf
10/19/2009 SUPPL-124 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/007073s124lbl.pdf
08/17/2001 SUPPL-115 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/7073s115lbl.pdf

AZULFIDINE

TABLET;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZULFIDINE SULFASALAZINE 500MG TABLET;ORAL Prescription Yes AB 007073 PHARMACIA AND UPJOHN
SULFASALAZINE SULFASALAZINE 500MG TABLET;ORAL Prescription No AB 040349 VINTAGE PHARMS
SULFASALAZINE SULFASALAZINE 500MG TABLET;ORAL Prescription No AB 085828 WATSON LABS

AZULFIDINE EN-TABS

TABLET, DELAYED RELEASE;ORAL; 500MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AZULFIDINE EN-TABS SULFASALAZINE 500MG TABLET, DELAYED RELEASE;ORAL Prescription Yes AB 007073 PHARMACIA AND UPJOHN
SULFASALAZINE SULFASALAZINE 500MG TABLET, DELAYED RELEASE;ORAL Prescription No AB 075339 VINTAGE PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English