FDA.reportPublic FDA data

Application 021583

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEPO-SUBQ PROVERA 104MEDROXYPROGESTERONE ACETATEINJECTABLE;SUBCUTANEOUS104MG/0.65MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-4709Depo-SubQ Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-4709Depo-SubQ Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-4709Depo-SubQ Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-4709Depo-SubQ Proveramedroxyprogesterone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-4709Depo-SubQ Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84449SUPPL 2025-12-18
84410SUPPL 2025-12-15
80623SUPPL 2024-12-18
80600SUPPL 2024-12-17
79082SUPPL 2024-07-15
79063SUPPL 2024-07-15
65578SUPPL2020-12-11
65577SUPPL2020-12-11
65519SUPPL2020-12-08
65518SUPPL2020-12-08
61489SUPPL2019-12-31
61488SUPPL2019-12-31
61487SUPPL2019-12-31
61454SUPPL2019-12-26
61453SUPPL2019-12-26
61452SUPPL2019-12-26
52790SUPPL2018-03-02
47088SUPPL2017-02-01
47082SUPPL2017-02-01
46471SUPPL2016-12-22
46288SUPPL2016-12-20
45557SUPPL2016-10-19
45621SUPPL2016-10-17
15822SUPPL2015-02-03
5781SUPPL2015-02-02
15823SUPPL2015-01-29
5782SUPPL2015-01-26
28175SUPPL2009-07-17
15821SUPPL2009-07-16
15820SUPPL2007-10-10
5780SUPPL2007-10-10
42218ORIG2007-05-09
5779SUPPL2005-11-18
15819SUPPL2005-11-16
28174SUPPL2005-05-04
28173ORIG2004-12-30
15818ORIG2004-12-30