Megestrol Oral Tablet

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Companies, Inc. (2011-11-01)
Oldest Current Product
1988-08-08
License(s)
ANDA
RxNORM
ORAL TABLET\MEGESTROL
FDAOB
ORAL\TABLET\MEGESTROL ACETATE
SPL Active
ORAL\TABLET\MEGESTROL ACETATE
SPL Moiety
ORAL\TABLET\MEGESTROL

product(s) by strength(s)

megestrol acetate 20 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544603ANDARoxane Laboratories, Inc1995-09-29MEGESTROL ACETATEORALTABLETANDA07445832fb094e-0de3-4ef6-8d21-612ca4c65717
2000548603ANDARoxane Laboratories, Inc1995-09-29MEGESTROL ACETATEORALTABLETANDA07445832fb094e-0de3-4ef6-8d21-612ca4c65717
3005550606ANDABarr Laboratories Inc.1996-10-25MEGESTROL ACETATEORALTABLETANDA07462166573d39-f2a7-49fd-9ed2-97ac8f6e8456
4498840289ANDAPar Pharmaceutical Companies, Inc.1988-08-08MEGESTROL ACETATEORALTABLETANDA0724224f94daf8-ceb9-4577-ab71-8b7e3db7ff8e

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1510790434ANDAMylan Institutional Inc.1997-08-07MEGESTROL ACETATEORALTABLET005550606ANDA0746213ff650c9-5665-4fa3-8163-f8eed8dcb1bd
2551545390ANDACardinal Health2011-05-13MEGESTROL ACETATEORALTABLET510790434ANDA074621966e6708-c9d7-4ab5-b255-9cb43ab0be5d

megestrol acetate 40 mg oral tablet

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000544604ANDARoxane Laboratories, Inc1995-09-29MEGESTROL ACETATEORALTABLETANDA07445832fb094e-0de3-4ef6-8d21-612ca4c65717
2000548604ANDARoxane Laboratories, Inc1995-09-29MEGESTROL ACETATEORALTABLETANDA07445832fb094e-0de3-4ef6-8d21-612ca4c65717
3005550607ANDABarr Laboratories Inc.1995-11-30MEGESTROL ACETATEORALTABLETANDA07462166573d39-f2a7-49fd-9ed2-97ac8f6e8456
4009043571ANDAMajor2004-02-16MEGESTROL ACETATEORALTABLETANDA072423fb18e777-1b9c-475a-b986-5d526dd4a307
5498840290ANDAPar Pharmaceutical Companies, Inc.1988-08-08MEGESTROL ACETATEORALTABLETANDA0724234f94daf8-ceb9-4577-ab71-8b7e3db7ff8e

relabeler product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formequivalent productapplicationspl
1006153570ANDANcs Healthcare Of Ky, Inc Dba Vangard Labs1988-08-08MEGESTROL ACETATEORALTABLET498840290ANDA07242336fa98ee-9255-4c6e-9f7b-cc08992547ba
2510790435ANDAMylan Institutional Inc.1997-10-232015-01-31MEGESTROL ACETATEORALTABLET005550607ANDA0746213ff650c9-5665-4fa3-8163-f8eed8dcb1bd
3538080614ANDAState Of Florida Doh Central Pharmacy2009-07-01MEGESTROL ACETATEORALTABLET000548604ANDA0744588f8017b4-4645-4ec2-9603-945b17e2753f
4548681629ANDAPhysicians Total Care, Inc.2007-07-05MEGESTROL ACETATEORALTABLET498840290ANDA072423c5c5c629-8f85-440a-b8c9-f702272c2854
5551540734ANDACardinal Health2004-02-16MEGESTROL ACETATEORALTABLET009043571ANDA07242328e48915-28bd-4108-b6c0-0471acc9b3fc
6551540885ANDACardinal Health1995-11-30MEGESTROL ACETATEORALTABLET005550607ANDA0746219fbafd6d-93b6-4248-9d35-328fea4e9650
7551545516ANDACardinal Health2011-05-13MEGESTROL ACETATEORALTABLET510790435ANDA074621966e6708-c9d7-4ab5-b255-9cb43ab0be5d
8637390165ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2007-08-20MEGESTROL ACETATEORALTABLET498840290ANDA0724237dea36eb-93bf-4593-9160-c84dfec26ab5
9691890608ANDAAvera Mckennan Hospital2015-03-02MEGESTROL ACETATEORALTABLET005550607ANDA07462156923bea-54cb-4c59-90a9-993d0f8093db

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA070646MEGESTROL ACETATETrueUSL PHARMA INC1987-10-02ANDA070646_001
2ANDA070647MEGESTROL ACETATETrueUSL PHARMA INC1987-10-02ANDA070647_001
3ANDA072422MEGESTROL ACETATEPAR PHARMACEUTICAL INC1988-08-08ANDA072422_001
4ANDA072423MEGESTROL ACETATEPAR PHARMACEUTICAL INC1988-08-08ANDA072423_001
5ANDA074458MEGESTROL ACETATEROXANE LABORATORIES INC1995-09-29ANDA074458_001, ANDA074458_002
6ANDA074621MEGESTROL ACETATEBARR LABORATORIES INC1995-11-30ANDA074621_001, ANDA074621_002
7ANDA074745MEGESTROL ACETATETrueTEVA PHARMACEUTICALS USA INC1998-02-27ANDA074745_001
8NDA016979MEGACETrueBRISTOL MYERS SQUIBBNDA016979_001, NDA016979_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA070646_001discontinuedMEGESTROL ACETATE (20MG)ORALTABLETFalse1987-10-02MEGESTROL ACETATE
2ANDA070647_001discontinuedMEGESTROL ACETATE (40MG)ORALTABLETFalse1987-10-02MEGESTROL ACETATE
3ANDA072422_001RXMEGESTROL ACETATE (20MG)ORALTABLETFalseAB1988-08-08MEGESTROL ACETATE
4ANDA072423_001RXMEGESTROL ACETATE (40MG)ORALTABLETTrueAB1988-08-08MEGESTROL ACETATE
5ANDA074458_001RXMEGESTROL ACETATE (20MG)ORALTABLETFalseAB1995-09-29MEGESTROL ACETATE
6ANDA074458_002RXMEGESTROL ACETATE (40MG)ORALTABLETFalseAB1995-09-29MEGESTROL ACETATE
7ANDA074621_001RXMEGESTROL ACETATE (40MG)ORALTABLETFalseAB1995-11-30MEGESTROL ACETATE
8ANDA074621_002RXMEGESTROL ACETATE (20MG)ORALTABLETFalseAB1996-08-16MEGESTROL ACETATE
9ANDA074745_001discontinuedMEGESTROL ACETATE (40MG)ORALTABLETFalse1998-02-27MEGESTROL ACETATE
10NDA016979_001discontinuedMEGESTROL ACETATE (20MG)ORALTABLETFalseMEGACE
11NDA016979_002discontinuedMEGESTROL ACETATE (40MG)ORALTABLETFalseMEGACE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
128e48915-28bd-4108-b6c0-0471acc9b3fc (view SPL)Megestrol Acetate TabletsprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-222551540734
232fb094e-0de3-4ef6-8d21-612ca4c65717 (view SPL)MEGESTROL ACETATE TABLETS USP, 20 mg AND 40 mgprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-10-265000544603, 000544604, 000548603, 000548604
336fa98ee-9255-4c6e-9f7b-cc08992547ba (view SPL)MEGESTROL ACETATE TABLETS, USPRx onlyprescriptionHuman PrescriptionNcs Healthcare Of Ky, Inc Dba Vangard LabsRELABEL, REPACK2013-07-094006153570
43ff650c9-5665-4fa3-8163-f8eed8dcb1bd (view SPL)MEGESTROL ACETATE TABLETS USPprescriptionHuman PrescriptionMylan Institutional Inc.2015-09-042510790434, 510790435
54f94daf8-ceb9-4577-ab71-8b7e3db7ff8e (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.2011-11-015498840289, 498840290
656923bea-54cb-4c59-90a9-993d0f8093db (view SPL)MEGESTROL ACETATE TABLETS USPprescriptionHuman PrescriptionAvera Mckennan Hospitalrelabel, repack2015-10-291691890608
766573d39-f2a7-49fd-9ed2-97ac8f6e8456 (view SPL)MEGESTROL ACETATE TABLETS USPprescriptionHuman PrescriptionBarr Laboratories Inc.2013-09-275005550606, 005550607
87dea36eb-93bf-4593-9160-c84dfec26ab5 (view SPL)Megestrol Acetate Tablets, USP Revised 09/07prescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2014-02-042637390165
98f8017b4-4645-4ec2-9603-945b17e2753f (view SPL)MEGESTROL ACETATE TABLETS USP, 20 MG AND 40 MGprescriptionHuman PrescriptionState Of Florida Doh Central Pharmacyrepack2010-06-071538080614
10966e6708-c9d7-4ab5-b255-9cb43ab0be5d (view SPL)MEGESTROL ACETATE TABLETS USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-06-305551545390, 551545516
119fbafd6d-93b6-4248-9d35-328fea4e9650 (view SPL)MEGESTROL ACETATE TABLETS USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-04-242551540885
12c5c5c629-8f85-440a-b8c9-f702272c2854 (view SPL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2012-09-184548681629
13fb18e777-1b9c-475a-b986-5d526dd4a307 (view SPL)Megestrol Acetate TabletsprescriptionHuman PrescriptionMajor2012-07-122009043571

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