Drugs@FDA: FDA-Approved Drugs
Company: PFIZER
| 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 |
|---|---|---|---|---|---|
| 11/16/2022 | SUPPL-133 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/007073s133lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/007073Orig1s133,020465Orig1s000,021243Orig1s000ltr.pdf | |
| 11/01/2021 | SUPPL-130 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007073s130lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/007073Orig1s130; 020465Orig1s000ltr.pdf | |
| 01/15/2021 | SUPPL-129 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007073s129lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/007073Orig1s129ltr.pdf | |
| 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 |
|---|---|---|---|---|---|
| 11/16/2022 | SUPPL-133 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/007073s133lbl.pdf | |
| 11/01/2021 | SUPPL-130 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007073s130lbl.pdf | |
| 01/15/2021 | SUPPL-129 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/007073s129lbl.pdf | |
| 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 | PFIZER |
| SULFASALAZINE | SULFASALAZINE | 500MG | TABLET;ORAL | Prescription | No | AB | 080197 | CHARTWELL |
| SULFASALAZINE | SULFASALAZINE | 500MG | TABLET;ORAL | Prescription | No | AB | 040349 | NUVO PHARMS INC |
| 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 | PFIZER |
| SULFASALAZINE | SULFASALAZINE | 500MG | TABLET, DELAYED RELEASE;ORAL | Prescription | No | AB | 075339 | NUVO PHARMS INC |