Documents
Application Sponsors
| NDA 021583 | PHARMACIA AND UPJOHN | |
Marketing Status
Application Products
| 001 | INJECTABLE;SUBCUTANEOUS | 104MG/0.65ML | 1 | DEPO-SUBQ PROVERA 104 | MEDROXYPROGESTERONE ACETATE |
FDA Submissions
| TYPE 3; Type 3 - New Dosage Form | ORIG | 1 | AP | 2004-12-17 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2005-11-08 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2007-10-05 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 11 | AP | 2009-07-15 | N/A |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 13 | AP | 2016-02-29 | STANDARD |
| LABELING; Labeling | SUPPL | 16 | AP | 2019-12-23 | UNKNOWN |
| LABELING; Labeling | SUPPL | 17 | AP | 2018-03-01 | UNKNOWN |
| LABELING; Labeling | SUPPL | 23 | AP | 2017-01-31 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2019-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 25 | AP | 2015-01-30 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2015-01-23 | STANDARD |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 27 | AP | 2016-08-04 | STANDARD |
| LABELING; Labeling | SUPPL | 29 | AP | 2019-12-23 | STANDARD |
| LABELING; Labeling | SUPPL | 31 | AP | 2016-12-16 | STANDARD |
| LABELING; Labeling | SUPPL | 32 | AP | 2016-10-14 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 33 | AP | 2020-12-04 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 34 | AP | 2020-12-04 | STANDARD |
Submissions Property Types
| SUPPL | 13 | Null | 0 |
| SUPPL | 16 | Null | 7 |
| SUPPL | 17 | Null | 15 |
| SUPPL | 23 | Null | 7 |
| SUPPL | 24 | Null | 7 |
| SUPPL | 25 | Null | 15 |
| SUPPL | 26 | Null | 6 |
| SUPPL | 29 | Null | 7 |
| SUPPL | 31 | Null | 6 |
| SUPPL | 32 | Null | 7 |
| SUPPL | 33 | Null | 15 |
| SUPPL | 34 | Null | 6 |
CDER Filings
PFIZER
cder:Array
(
[0] => Array
(
[ApplNo] => 21583
[companyName] => PFIZER
[docInserts] => ["",""]
[products] => [{"drugName":"DEPO-SUBQ PROVERA 104","activeIngredients":"MEDROXYPROGESTERONE ACETATE","strength":"104MG\/0.65ML","dosageForm":"INJECTABLE;SUBCUTANEOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"12\/04\/2020","submission":"SUPPL-34","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021583s033s034lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2020","submission":"SUPPL-33","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/021583s033s034lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2019","submission":"SUPPL-29","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/23\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/23\/2019","submission":"SUPPL-24","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"12\/23\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""},{"actionDate":"01\/31\/2017","submission":"SUPPL-23","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/021583s023lbl.pdf\"}]","notes":""},{"actionDate":"12\/16\/2016","submission":"SUPPL-31","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021583s031lbl.pdf\"}]","notes":""},{"actionDate":"10\/14\/2016","submission":"SUPPL-32","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/021583s032lbl.pdf\"}]","notes":""},{"actionDate":"01\/30\/2015","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/021583s025lbl.pdf\"}]","notes":""},{"actionDate":"01\/23\/2015","submission":"SUPPL-26","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020246s054,021583s026lbl.pdf\"}]","notes":""},{"actionDate":"07\/15\/2009","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021583s011lbl.pdf\"}]","notes":""},{"actionDate":"10\/05\/2007","submission":"SUPPL-6","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021583s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/08\/2005","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/021583s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/17\/2004","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/021583lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"DEPO-SUBQ PROVERA 104","submission":"MEDROXYPROGESTERONE ACETATE","actionType":"104MG\/0.65ML","submissionClassification":"INJECTABLE;SUBCUTANEOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
[supplements] =>
[actionDate] => 2020-12-04
)
)