Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021583
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEPO-SUBQ PROVERA 104 | MEDROXYPROGESTERONE ACETATE | 104MG/0.65ML | INJECTABLE;SUBCUTANEOUS | Prescription | None | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/12/2025 | SUPPL-45 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020246s074lbl021583s045lbl.pdf#page=28 | |
| 12/12/2025 | SUPPL-45 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020246s074lbl021583s045lbl.pdf#page=28 | |
| 12/16/2024 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021583s043lbl.pdf | |
| 07/11/2024 | SUPPL-40 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021583s040lbl.pdf | |
| 12/04/2020 | SUPPL-34 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021583s033s034lbl.pdf | |
| 12/04/2020 | SUPPL-33 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021583s033s034lbl.pdf | |
| 12/23/2019 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf | |
| 12/23/2019 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf | |
| 12/23/2019 | SUPPL-24 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf | |
| 12/23/2019 | SUPPL-16 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf | |
| 01/31/2017 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021583s023lbl.pdf | |
| 12/16/2016 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s031lbl.pdf | |
| 10/14/2016 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s032lbl.pdf | |
| 01/30/2015 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021583s025lbl.pdf | |
| 01/23/2015 | SUPPL-26 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s054,021583s026lbl.pdf | |
| 07/15/2009 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021583s011lbl.pdf | |
| 10/05/2007 | SUPPL-6 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021583s006lbl.pdf | |
| 11/08/2005 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021583s003lbl.pdf | |
| 12/17/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021583lbl.pdf |