Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 007073
Company: PFIZER
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 |
| 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 |