Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020246
Company: PFIZER
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)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020246Orig1s063ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/020246Orig1s060s062.pdf |
| 12/04/2020 | SUPPL-62 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020246s060s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020246Orig1s060, s062ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/020246Orig1s060s062.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 | 215397 | AMNEAL |
| 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 | 076553 | HONG KONG |
| MEDROXYPROGESTERONE ACETATE | MEDROXYPROGESTERONE ACETATE | 150MG/ML | INJECTABLE;INJECTION | Prescription | No | AB | 210227 | MYLAN LABS LTD |