Drugs@FDA: FDA-Approved Drugs
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-Package Insert, Labeling-Container/Carton Labels |
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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/011839Orig1s078lbl.pdf | |
09/18/2023 | SUPPL-78 | Labeling-Container/Carton Labels | 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 |