FDA.reportPublic FDA data

Application 011839

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROVERAMEDROXYPROGESTERONE ACETATETABLET;ORAL2.5MGYesNo
003PROVERAMEDROXYPROGESTERONE ACETATETABLET;ORAL5MGYesNo
004PROVERAMEDROXYPROGESTERONE ACETATETABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0050Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0050Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0050Proveramedroxyprogesterone acetatePharmacia and Upjohn CompanyNDACurrent
0009-0050Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0050Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0051Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0051Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0051Proveramedroxyprogesterone acetatePharmacia and Upjohn CompanyNDACurrent
0009-0051Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0051Proveramedroxyprogesterone acetatePharmacia and Upjohn CompanyNDACurrent
0009-0064Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0064Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0064Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0065Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0065Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0065Proveramedroxyprogesterone acetatePharmacia and Upjohn CompanyNDACurrent
0009-0065Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0065Proveramedroxyprogesterone acetatePharmacia and Upjohn CompanyNDACurrent
0009-0286Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0286Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0286Proveramedroxyprogesterone acetatePharmacia and Upjohn CompanyNDACurrent
0009-0286Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0286Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0286Proveramedroxyprogesterone acetatePharmacia and Upjohn CompanyNDACurrent
0009-0287Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0287Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0287Proveramedroxyprogesterone acetatePharmacia and Upjohn CompanyNDACurrent
0009-0287Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0287Proveramedroxyprogesterone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0287Proveramedroxyprogesterone acetatePharmacia and Upjohn CompanyNDACurrent
43063-438medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-438medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-438medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
43063-438medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-816medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-816medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-816medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-816medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-816medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-816medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-816medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-908medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-908medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-908medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-908medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-908medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-908medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55289-908medroxyprogesterone acetatemedroxyprogesterone acetatePD-Rx Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
55700-699medroxyprogesterone acetatemedroxyprogesterone acetateQuality Care Products, LLCNDA AUTHORIZED GENERICCurrent
59762-0055medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0055medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0055medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0055medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0055medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0055medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0055medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0055medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0055medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED Current
59762-0055medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0056medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0056medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0056medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0056medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0056medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0056medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0056medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0056medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0058medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0058medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0058medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0058medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0058medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0058medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0058medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0058medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0058medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3740medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3740medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3740medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-3740medroxyprogesterone acetatemedroxyprogesterone acetateGreenstone LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77563SUPPL 2024-02-20
77538SUPPL 2024-02-16
75986SUPPL 2023-10-30
75983SUPPL 2023-10-30
11968SUPPL2015-05-11
290SUPPL2015-05-11
10783SUPPL2015-05-08
10782SUPPL2015-05-08
11967SUPPL2007-10-04
10781SUPPL2007-10-04
40676SUPPL1998-08-04
11966SUPPL1998-08-04