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 |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/17/2004 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021583lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021583ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021583s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/11/2024 | SUPPL-40 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021583s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021583Orig1s040ltr.pdf | |
12/04/2020 | SUPPL-34 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021583s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021583Orig1s033, s034ltr.pdf | |
12/04/2020 | SUPPL-33 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021583s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021583Orig1s033, s034ltr.pdf | |
10/14/2016 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021583Orig1s032ltr.pdf | |
12/16/2016 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021583s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021583Orig1s031ltr.pdf | |
12/23/2019 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021583Orig1s016, s024, s029ltr.pdf | |
08/04/2016 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/23/2015 | SUPPL-26 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s054,021583s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020246Orig1s054,021583Orig1s026ltr.pdf | |
01/30/2015 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021583s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021583Orig1s025ltr.pdf | |
12/23/2019 | SUPPL-24 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021583Orig1s016, s024, s029ltr.pdf | |
01/31/2017 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021583s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021583Orig1s023ltr.pdf | |
03/01/2018 | SUPPL-17 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021583s17ltr.pdf |
12/23/2019 | SUPPL-16 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021583s016, s024, s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021583Orig1s016, s024, s029ltr.pdf | |
02/29/2016 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/15/2009 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021583s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021583s011ltr.pdf | |
10/05/2007 | SUPPL-6 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021583s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021583s006ltr.pdf | |
11/08/2005 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021583s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021583s003ltr.pdf | |
05/02/2005 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021583s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
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 |