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New Drug Application (NDA): 020246
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEPO-PROVERA MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE;INJECTION Prescription AB 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
10/29/1992 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/16/2017 SUPPL-63 Labeling-Container/Carton Labels Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020246Orig1s063ltr.pdf
12/04/2020 SUPPL-62 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s060s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020246Orig1s060, s062ltr.pdf
12/04/2020 SUPPL-60 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s060s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020246Orig1s060, s062ltr.pdf
12/16/2016 SUPPL-58 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020246s058lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020246Orig1s058ltr.pdf
09/09/2020 SUPPL-57 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s043s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020246Orig1s043, s057ltr.pdf
01/23/2015 SUPPL-54 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-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020246Orig1s053ltr.pdf
06/09/2014 SUPPL-52 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/20246Orig1s052.pdf
09/27/2013 SUPPL-50 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/20246Orig1s050.pdf
09/10/2013 SUPPL-49 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/20246Orig1s049.pdf
03/25/2013 SUPPL-48 Manufacturing (CMC) Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/20246Orig1s048.pdf
09/09/2020 SUPPL-43 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s043s057lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020246Orig1s043, s057ltr.pdf
02/24/2016 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

10/15/2010 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020246s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020246s036ltr.pdf
07/28/2011 SUPPL-35 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020246s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020246s035ltr.pdf
11/17/2004 SUPPL-25 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20246s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20246s025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020246Orig1s025.pdf
05/23/2003 SUPPL-19 Manufacturing (CMC)-Control Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20246scs019_Depo-provera_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20246scs019ltr.pdf
05/23/2002 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

04/26/2002 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/2001 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/03/2000 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/28/2005 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020246s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020246s013ltr.pdf
08/12/1998 SUPPL-12 Labeling

Label is not available on this site.

01/31/1997 SUPPL-11 Labeling

Label is not available on this site.

03/20/1996 SUPPL-9 Labeling

Label is not available on this site.

11/28/1995 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

05/03/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

02/01/1996 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1994 SUPPL-4 Labeling

Label is not available on this site.

12/01/1994 SUPPL-3 Labeling

Label is not available on this site.

02/17/1994 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/04/2020 SUPPL-62 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s060s062lbl.pdf
12/04/2020 SUPPL-60 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s060s062lbl.pdf
09/09/2020 SUPPL-57 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s043s057lbl.pdf
09/09/2020 SUPPL-43 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s043s057lbl.pdf
12/16/2016 SUPPL-58 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020246s058lbl.pdf
01/30/2015 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s053lbl.pdf
01/23/2015 SUPPL-54 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020246s054,021583s026lbl.pdf
07/28/2011 SUPPL-35 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020246s035lbl.pdf
10/15/2010 SUPPL-36 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020246s036lbl.pdf
10/28/2005 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020246s013lbl.pdf
11/17/2004 SUPPL-25 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20246s025lbl.pdf
05/23/2003 SUPPL-19 Manufacturing (CMC)-Control Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20246scs019_Depo-provera_lbl.pdf

DEPO-PROVERA

INJECTABLE;INJECTION; 150MG/ML
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEPO-PROVERA MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE;INJECTION Prescription Yes AB 020246 PFIZER
MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE;INJECTION Prescription No AB 077235 AMPHASTAR PHARMS INC
MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE;INJECTION Prescription No AB 077334 AMPHASTAR PHARMS INC
MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE;INJECTION Prescription No AB 212824 EUGIA PHARMA
MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE;INJECTION Prescription No AB 212844 EUGIA PHARMA
MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE;INJECTION Prescription No AB 210227 MYLAN LABS LTD
MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE 150MG/ML INJECTABLE;INJECTION Prescription No AB 076553 TEVA PHARMS USA
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