Drugs@FDA: FDA-Approved Drugs
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| MEDROXYPROGESTERONE ACETATE | 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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. |
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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. |
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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 |