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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011839
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROVERA MEDROXYPROGESTERONE ACETATE 2.5MG TABLET;ORAL Prescription AB Yes No
PROVERA MEDROXYPROGESTERONE ACETATE 5MG TABLET;ORAL Prescription AB Yes No
PROVERA MEDROXYPROGESTERONE ACETATE 10MG TABLET;ORAL 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
06/18/1959 ORIG-1 Approval Type 1 - New Molecular Entity 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
02/15/2024 SUPPL-83 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011839s083lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/011839Orig1s083ltr.pdf
05/07/2015 SUPPL-80 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011839Orig1s079,s080ltr.pdf
05/07/2015 SUPPL-79 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011839Orig1s079,s080ltr.pdf
09/18/2023 SUPPL-78 Labeling-Container/Carton Labels, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011839Orig1s078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/011839Orig1s078ltr.pdf
12/01/2016 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.
09/28/2007 SUPPL-71 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011839s071lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011839s071ltr.pdf
08/04/1998 SUPPL-68 Efficacy-New Indication Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/11839S68LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/11839-S068_Provera.pdf
03/31/1998 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.
06/23/1993 SUPPL-63 Manufacturing (CMC)-Packaging

Label is not available on this site.
04/30/1993 SUPPL-62 Labeling

Label is not available on this site.
06/23/1993 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.
11/19/1991 SUPPL-60 Labeling

Label is not available on this site.
06/19/1992 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.
12/18/1991 SUPPL-58 Labeling

Label is not available on this site.
10/06/1989 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.
06/03/1988 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.
10/26/1987 SUPPL-50 Labeling

Label is not available on this site.
11/01/1985 SUPPL-46 Manufacturing (CMC)-Formulation

Label is not available on this site.
07/23/1979 SUPPL-39 Efficacy

Label is not available on this site.
06/06/1979 SUPPL-35 Efficacy

Label is not available on this site.
10/21/1975 SUPPL-29 Unspecified

Label is not available on this site.
10/04/1973 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
02/15/2024 SUPPL-83 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/011839s083lbl.pdf
09/18/2023 SUPPL-78 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011839Orig1s078lbl.pdf
09/18/2023 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011839Orig1s078lbl.pdf
05/07/2015 SUPPL-80 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf
05/07/2015 SUPPL-79 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf
09/28/2007 SUPPL-71 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011839s071lbl.pdf

PROVERA

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE 2.5MG TABLET;ORAL Prescription No AB 040159 BARR
PROVERA MEDROXYPROGESTERONE ACETATE 2.5MG TABLET;ORAL Prescription Yes AB 011839 PFIZER

TABLET;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE 5MG TABLET;ORAL Prescription No AB 040159 BARR
PROVERA MEDROXYPROGESTERONE ACETATE 5MG TABLET;ORAL Prescription Yes AB 011839 PFIZER

TABLET;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MEDROXYPROGESTERONE ACETATE MEDROXYPROGESTERONE ACETATE 10MG TABLET;ORAL Prescription No AB 040159 BARR
PROVERA MEDROXYPROGESTERONE ACETATE 10MG TABLET;ORAL Prescription Yes AB 011839 PFIZER
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