Medroxyprogesterone Oral Tablet

Brand(s)
Provera
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2015-08-18)
Oldest Current Product
1959-06-03
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL TABLET\MEDROXYPROGESTERONE
FDAOB
ORAL\TABLET\MEDROXYPROGESTERONE ACETATE
SPL Active
ORAL\TABLET\MEDROXYPROGESTERONE ACETATE
SPL Moiety
ORAL\TABLET\MEDROXYPROGESTERONE

product(s) by strength(s)

medroxyprogesterone acetate 10 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090050ProveraNDAPharmacia And Upjohn Company1959-06-03MEDROXYPROGESTERONE ACETATEORALTABLETNDA011839a586be28-96af-4fed-a13f-9b94fd4c7405

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005550779ANDABarr Laboratories Inc.1996-12-04MEDROXYPROGESTERONE ACETATEORALTABLETANDA0401599eb200b0-db96-4a51-87ea-04db862978c8
2597623742NDA AUTHORIZED GENERICGreenstone Llc1959-06-03MEDROXYPROGESTERONE ACETATEORALTABLETNDA0118392627eb11-06bf-4a45-9172-094468e3ca07

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440062ANDABlenheim Pharmacal, Inc.2010-05-20MEDROXYPROGESTERONE ACETATEORALTABLET005550779ANDA040159826f674c-8ef2-400a-bf0b-877320a8cb5d
2216950896ANDARebel Distributors Corp1996-08-09MEDROXYPROGESTERONE ACETATEORALTABLET005550779ANDA040159e5f5c46c-b8b7-4502-9d2b-8f12284d1a63
3332610534ANDAAidarex Pharmaceuticals Llc1996-12-04MEDROXYPROGESTERONE ACETATEORALTABLET005550779ANDA040159fda3368b-4ce3-4972-885d-066858831ee0
4430630438NDA AUTHORIZED GENERICPd-Rx Pharmaceuticals, Inc.1959-06-03MEDROXYPROGESTERONE ACETATEORALTABLET597623742NDA011839e1d5975a-e0e5-444d-bab0-3904c3f377c9
5493490287NDA AUTHORIZED GENERICRemedyrepack Inc.2011-06-07, 2014-12-30MEDROXYPROGESTERONE ACETATEORALTABLET597623742NDA011839468a972c-cb14-47c3-bdf6-4f7b64509e5c, 519f68cd-0751-4117-971b-f928dccdf5ba
6521250562ANDARemedyrepack Inc.2013-05-23MEDROXYPROGESTERONE ACETATEORALTABLET005550779ANDA040159bc417aba-2b32-4943-9031-ff2bf79c2dcb
7521250803ANDARemedyrepack Inc.2014-01-09MEDROXYPROGESTERONE ACETATEORALTABLET005550779ANDA04015951588bf9-ad2f-42d5-83a7-3431b6e891e3
8545690809ANDAA-S Medication Solutions Llc1996-12-04MEDROXYPROGESTERONE ACETATEORALTABLET005550779ANDA040159b1a02aba-b398-46c4-b98b-7064797aaa4b
9548680109NDA AUTHORIZED GENERICPhysicians Total Care, Inc.1994-07-06MEDROXYPROGESTERONE ACETATEORALTABLET597623742NDA011839499051ac-ffaf-4db4-be45-a409bd54991f
10551540533NDA AUTHORIZED GENERICCardinal Health1959-06-03MEDROXYPROGESTERONE ACETATEORALTABLET597623742NDA011839d2c3d585-3b01-448b-a630-3ea9aa34bccb
11552890160ANDAPd-Rx Pharmaceuticals, Inc.2011-01-18MEDROXYPROGESTERONE ACETATEORALTABLET005550779ANDA040159437edd12-2c08-4df4-8cf7-64c47e4779ac
12606870105ANDAAmerican Health Packaging2015-03-31MEDROXYPROGESTERONE ACETATEORALTABLET005550779ANDA040159cbf142f9-9af3-4d79-9343-0ab42d6dbe9f
13636292612ANDABryant Ranch Prepack1996-12-04MEDROXYPROGESTERONE ACETATEORALTABLET005550779ANDA040159bdb89690-ced2-48e1-bb1a-e5eccfeda8eb
14642050077ANDAReadymeds1996-12-04MEDROXYPROGESTERONE ACETATEORALTABLET005550779ANDA040159ec517411-6d3d-4cb1-a50e-f0818d03b0e4
15687889899ANDAPreferred Pharmaceuticals, Inc.2012-02-13MEDROXYPROGESTERONE ACETATEORALTABLET005550779ANDA04015937275fd0-eb24-40a4-a93f-b818bb98414e

medroxyprogesterone acetate 2.5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090064ProveraNDAPharmacia And Upjohn Company1959-06-03MEDROXYPROGESTERONE ACETATEORALTABLETNDA011839a586be28-96af-4fed-a13f-9b94fd4c7405

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005550872ANDABarr Laboratories Inc.1996-12-04MEDROXYPROGESTERONE ACETATEORALTABLETANDA0401599eb200b0-db96-4a51-87ea-04db862978c8
2597623740NDA AUTHORIZED GENERICGreenstone Llc1959-06-03MEDROXYPROGESTERONE ACETATEORALTABLETNDA0118392627eb11-06bf-4a45-9172-094468e3ca07

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1332610609ANDAAidarex Pharmaceuticals Llc1996-12-04MEDROXYPROGESTERONE ACETATEORALTABLET005550872ANDA040159fda3368b-4ce3-4972-885d-066858831ee0
2548682984NDA AUTHORIZED GENERICPhysicians Total Care, Inc.1995-04-24MEDROXYPROGESTERONE ACETATEORALTABLET597623740NDA011839499051ac-ffaf-4db4-be45-a409bd54991f
3552890816NDA AUTHORIZED GENERICPd-Rx Pharmaceuticals, Inc.1959-06-03MEDROXYPROGESTERONE ACETATEORALTABLET597623740NDA0118390930a471-6ff1-43a1-b3ea-948ca3f99d06
4636292613ANDABryant Ranch Prepack1996-12-04MEDROXYPROGESTERONE ACETATEORALTABLET005550872ANDA04015993b7c9e8-fa4a-4b6f-879f-d71fd251e349
5642050087ANDAReadymeds1996-12-04MEDROXYPROGESTERONE ACETATEORALTABLET005550872ANDA040159ec517411-6d3d-4cb1-a50e-f0818d03b0e4
6680840553NDA AUTHORIZED GENERICAmerican Health Packaging2012-01-272015-12-31MEDROXYPROGESTERONE ACETATEORALTABLET597623740NDA01183960cf7eda-3ee3-4f26-96be-ec97e4058735

medroxyprogesterone acetate 5 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090286ProveraNDAPharmacia And Upjohn Company1959-06-03MEDROXYPROGESTERONE ACETATEORALTABLETNDA011839a586be28-96af-4fed-a13f-9b94fd4c7405

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005550873ANDABarr Laboratories Inc.1996-12-03MEDROXYPROGESTERONE ACETATEORALTABLETANDA0401599eb200b0-db96-4a51-87ea-04db862978c8
2597623741NDA AUTHORIZED GENERICGreenstone Llc1959-06-03MEDROXYPROGESTERONE ACETATEORALTABLETNDA0118392627eb11-06bf-4a45-9172-094468e3ca07

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1105440001ANDABlenheim Pharmacal, Inc.2010-05-20MEDROXYPROGESTERONE ACETATEORALTABLET005550873ANDA040159826f674c-8ef2-400a-bf0b-877320a8cb5d
2332610740ANDAAidarex Pharmaceuticals Llc1996-12-03MEDROXYPROGESTERONE ACETATEORALTABLET005550873ANDA040159fda3368b-4ce3-4972-885d-066858831ee0
3545693807ANDAA-S Medication Solutions Llc1996-12-03MEDROXYPROGESTERONE ACETATEORALTABLET005550873ANDA040159b1a02aba-b398-46c4-b98b-7064797aaa4b
4548682985NDA AUTHORIZED GENERICPhysicians Total Care, Inc.1995-09-19MEDROXYPROGESTERONE ACETATEORALTABLET597623741NDA011839499051ac-ffaf-4db4-be45-a409bd54991f
5636292614ANDABryant Ranch Prepack1996-12-03MEDROXYPROGESTERONE ACETATEORALTABLET005550873ANDA04015904d23262-b778-4815-b56f-6ca6fef826c0
6663360603ANDADispensing Solutions, Inc.2011-01-18MEDROXYPROGESTERONE ACETATEORALTABLET005550873ANDA040159210a9132-8837-4b8a-829c-abfac2d6e3dc

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040159MEDROXYPROGESTERONE ACETATEBARR LABORATORIES INC1996-08-09ANDA040159_001, ANDA040159_002, ANDA040159_003
2ANDA040311MEDROXYPROGESTERONE ACETATETrueDURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC1999-12-01ANDA040311_001, ANDA040311_002, ANDA040311_003
3ANDA081239CYCRINTrueESI PHARMACAL1992-10-30ANDA081239_001
4ANDA081240CYCRINTrueESI PHARMACAL1992-10-30ANDA081240_001
5ANDA083242AMENTrueAMARIN PHARMACEUTICALS INCANDA083242_001
6ANDA085686CURRETABTrueSOLVAY PHARMACEUTICALSANDA085686_001
7ANDA088484MEDROXYPROGESTERONE ACETATETrueUSL PHARMA INC1984-07-26ANDA088484_001
8ANDA089386CYCRINTrueESI PHARMACAL1987-09-09ANDA089386_001
9NDA011839PROVERAPHARMACIA AND UPJOHN CONDA011839_001, NDA011839_003, NDA011839_004

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040159_001RXMEDROXYPROGESTERONE ACETATE (2.5MG)ORALTABLETFalseAB1996-08-09MEDROXYPROGESTERONE ACETATE
2ANDA040159_002RXMEDROXYPROGESTERONE ACETATE (5MG)ORALTABLETFalseAB1996-08-09MEDROXYPROGESTERONE ACETATE
3ANDA040159_003RXMEDROXYPROGESTERONE ACETATE (10MG)ORALTABLETFalseAB1996-08-09MEDROXYPROGESTERONE ACETATE
4ANDA040311_001discontinuedMEDROXYPROGESTERONE ACETATE (2.5MG)ORALTABLETFalse1999-12-01MEDROXYPROGESTERONE ACETATE
5ANDA040311_002discontinuedMEDROXYPROGESTERONE ACETATE (5MG)ORALTABLETFalse1999-12-01MEDROXYPROGESTERONE ACETATE
6ANDA040311_003discontinuedMEDROXYPROGESTERONE ACETATE (10MG)ORALTABLETFalse1999-12-01MEDROXYPROGESTERONE ACETATE
7ANDA081239_001discontinuedMEDROXYPROGESTERONE ACETATE (2.5MG)ORALTABLETFalse1992-10-30CYCRIN
8ANDA081240_001discontinuedMEDROXYPROGESTERONE ACETATE (5MG)ORALTABLETFalse1992-10-30CYCRIN
9ANDA083242_001discontinuedMEDROXYPROGESTERONE ACETATE (10MG)ORALTABLETFalseAMEN
10ANDA085686_001discontinuedMEDROXYPROGESTERONE ACETATE (10MG)ORALTABLETFalseCURRETAB
11ANDA088484_001discontinuedMEDROXYPROGESTERONE ACETATE (10MG)ORALTABLETFalse1984-07-26MEDROXYPROGESTERONE ACETATE
12ANDA089386_001discontinuedMEDROXYPROGESTERONE ACETATE (10MG)ORALTABLETFalse1987-09-09CYCRIN
13NDA011839_001RXMEDROXYPROGESTERONE ACETATE (2.5MG)ORALTABLETFalseABPROVERA
14NDA011839_003RXMEDROXYPROGESTERONE ACETATE (5MG)ORALTABLETFalseABPROVERA
15NDA011839_004RXMEDROXYPROGESTERONE ACETATE (10MG)ORALTABLETTrueABPROVERA

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
104d23262-b778-4815-b56f-6ca6fef826c0 (view SPL)Medroxyprogesterone Acetate Tablets USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2013-01-171000636292614
20930a471-6ff1-43a1-b3ea-948ca3f99d06 (view SPL)Medroxyprogesterone Acetate Tablets, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2012-10-096552890816
3210a9132-8837-4b8a-829c-abfac2d6e3dc (view SPL)Medroxyprogesterone Acetate Tablets USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-09-282663360603
42627eb11-06bf-4a45-9172-094468e3ca07 (view SPL)Medroxyprogesterone Acetate Tablets, USPprescriptionHuman PrescriptionGreenstone LlcANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-07-139597623740, 597623741, 597623742
537275fd0-eb24-40a4-a93f-b818bb98414e (view SPL)Medroxyprogesterone Acetate Tablets USPprescriptionHuman PrescriptionPreferred Pharmaceuticals, Inc.REPACK2015-02-242687889899
6437edd12-2c08-4df4-8cf7-64c47e4779ac (view SPL)Medroxyprogesterone Acetate Tablets USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2011-01-182552890160
7468a972c-cb14-47c3-bdf6-4f7b64509e5c (view SPL)prescriptionHuman PrescriptionRemedyrepack Inc.2011-06-071493490287
8499051ac-ffaf-4db4-be45-a409bd54991f (view SPL)Medroxyprogesterone Acetate Tablets, USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2009-08-131548680109, 548682984, 548682985
951588bf9-ad2f-42d5-83a7-3431b6e891e3 (view SPL)Medroxyprogesterone Acetate Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-01-091521250803
10519f68cd-0751-4117-971b-f928dccdf5ba (view SPL)Medroxyprogesterone Acetate Tablets, USPprescriptionHuman PrescriptionRemedyrepack Inc.2014-12-301493490287
1160cf7eda-3ee3-4f26-96be-ec97e4058735 (view SPL)Medroxyprogesterone Acetate Tablets, USPprescriptionHuman PrescriptionAmerican Health Packagingrepack2015-10-013680840553
12826f674c-8ef2-400a-bf0b-877320a8cb5d (view SPL)Medroxyprogesterone Acetate Tablets USPprescriptionHuman PrescriptionBlenheim Pharmacal, Inc.repack2015-03-193105440001, 105440062
1393b7c9e8-fa4a-4b6f-879f-d71fd251e349 (view SPL)Medroxyprogesterone Acetate Tablets USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2015-05-071001636292613
149eb200b0-db96-4a51-87ea-04db862978c8 (view SPL)MedroxyPROGESTERone Acetate Tablets USPprescriptionHuman PrescriptionBarr Laboratories Inc.2015-11-208005550779, 005550872, 005550873
15a586be28-96af-4fed-a13f-9b94fd4c7405 (view SPL)PROVERA (medroxyprogesterone acetate tablets, USP)prescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-08-1812000090050, 000090064, 000090286
16b1a02aba-b398-46c4-b98b-7064797aaa4b (view SPL)Medroxyprogesterone Acetate Tablets USPprescriptionHuman PrescriptionA-S Medication Solutions Llcrepack2013-06-291545690809, 545693807
17bc417aba-2b32-4943-9031-ff2bf79c2dcb (view SPL)Medroxyprogesterone Acetate Tablets USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-05-231521250562
18bdb89690-ced2-48e1-bb1a-e5eccfeda8eb (view SPL)Medroxyprogesterone Acetate Tablets USPprescriptionHuman PrescriptionBryant Ranch PrepackRELABEL, REPACK2014-07-281001636292612
19cbf142f9-9af3-4d79-9343-0ab42d6dbe9f (view SPL)MEDROXYPROGESTERONE ACETATE TABLETS USPprescriptionHuman PrescriptionAmerican Health PackagingREPACK2015-04-061606870105
20d2c3d585-3b01-448b-a630-3ea9aa34bccb (view SPL)Medroxyprogesterone Acetate Tablets, USPprescriptionHuman PrescriptionCardinal HealthREPACK2011-06-102551540533
21e1d5975a-e0e5-444d-bab0-3904c3f377c9 (view SPL)Medroxyprogesterone Acetate Tablets, USPprescriptionHuman PrescriptionPd-Rx Pharmaceuticals, Inc.repack2015-11-168430630438
22e5f5c46c-b8b7-4502-9d2b-8f12284d1a63 (view SPL)MEDROXYPROGESTERONE ACETATE TABLETS, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2010-10-042216950896
23ec517411-6d3d-4cb1-a50e-f0818d03b0e4 (view SPL)Medroxyprogesterone Acetate Tablets USPprescriptionHuman PrescriptionReadymedsrepack2014-05-068642050077, 642050087
24fda3368b-4ce3-4972-885d-066858831ee0 (view SPL)Medroxyprogesterone Acetate Tablets USPprescriptionHuman PrescriptionAidarex Pharmaceuticals Llc2014-01-131332610534, 332610609, 332610740

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII