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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012541
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEPO-PROVERA MEDROXYPROGESTERONE ACETATE 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
DEPO-PROVERA MEDROXYPROGESTERONE ACETATE 400MG/ML INJECTABLE;INJECTION Discontinued None Yes No

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/23/1960 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/15/2017 SUPPL-88 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012541Orig1s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012541Orig1s088ltr.pdf
04/03/2017 SUPPL-86 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012541s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/012541Orig1s086ltr.pdf
12/16/2016 SUPPL-85 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012541s085lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012541Orig1s085ltr.pdf
06/10/2016 SUPPL-84 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012541s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012541Orig1s084ltr.pdf
06/11/2015 SUPPL-83 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012541s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/012541Orig1s083ltr.pdf
06/09/2014 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.
11/20/2012 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.
04/03/2000 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.
11/28/1997 SUPPL-67 Labeling

Label is not available on this site.
11/28/1995 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.
04/18/1995 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.
04/12/1995 SUPPL-64 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/27/1994 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.
06/16/1994 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.
02/17/1994 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.
02/18/1994 SUPPL-60 Labeling

Label is not available on this site.
06/23/1993 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.
09/07/1995 SUPPL-57 Labeling

Label is not available on this site.
02/20/1990 SUPPL-56 Labeling

Label is not available on this site.
05/20/1980 SUPPL-49 Manufacturing (CMC)

Label is not available on this site.
07/13/1979 SUPPL-48 Labeling

Label is not available on this site.
12/04/1978 SUPPL-42 Labeling

Label is not available on this site.
11/01/1976 SUPPL-41 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
11/01/1976 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.
11/01/1976 SUPPL-38 Labeling

Label is not available on this site.
01/19/1979 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.
01/16/1976 SUPPL-36 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/03/2017 SUPPL-86 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012541s086lbl.pdf
03/15/2017 SUPPL-88 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/012541Orig1s088lbl.pdf
12/16/2016 SUPPL-85 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012541s085lbl.pdf
06/10/2016 SUPPL-84 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012541s084lbl.pdf
06/11/2015 SUPPL-83 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/012541s083lbl.pdf
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