Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021583
Company: PHARMACIA AND UPJOHN
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
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
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
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
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
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

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