Megestrol Oral Suspension

Brand(s)
Megace
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Par Pharmaceutical Companies, Inc. (2015-07-28)
Oldest Current Product
2001-07-25
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL SUSPENSION\MEGESTROL
FDAOB
ORAL\SUSPENSION\MEGESTROL ACETATE
SPL Active
ORAL\SUSPENSION\MEGESTROL ACETATE
SPL Moiety
ORAL\SUSPENSION\MEGESTROL

product(s) by strength(s)

megestrol acetate 125 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840949MegaceNDAPar Pharmaceutical Companies, Inc.2005-07-02MEGESTROL ACETATEORALSUSPENSIONNDA021778f5525acb-a982-45e8-8265-a7d7a7974141

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1249790041ANDATwi Pharmaceuticals, Inc.2015-03-01MEGESTROL ACETATEORALSUSPENSIONANDA2031392dc921d5-e423-4379-a345-151e87d13651
2498840230NDA AUTHORIZED GENERICPar Pharmaceutical Companies, Inc.2015-07-28MEGESTROL ACETATEORALSUSPENSIONNDA0217789439c3c2-338a-4d5a-be71-62c71e255504

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900254MegaceNDAStat Rx Usa Llc2005-06-08MEGESTROL ACETATEORALSUSPENSION498840949NDA02177833bc102c-31a3-4fd9-9702-c1193d7699a3
2178560949MegaceNDAAtlantic Biologicals Corps2005-07-02MEGESTROL ACETATEORALSUSPENSION498840949NDA021778654854bc-f847-4e3b-a0a1-8716553460ac
3548685572MegaceNDAPhysicians Total Care, Inc.2006-04-13MEGESTROL ACETATEORALSUSPENSION49884094969NDA021778e3e96f8d-31a6-4457-8e05-02579b539b8a

megestrol acetate 40 mg/ml oral suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000150508MegaceNDAE.R. Squibb & Sons, L.L.C.2009-06-01MEGESTROL ACETATEORALSUSPENSIONNDA02026465b28775-ee59-88cf-e4d8-372c6c79ad14

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000543542ANDARoxane Laboratories, Inc2002-02-15MEGESTROL ACETATEORALSUSPENSIONANDA0759972bd8c04f-491c-4269-9281-642efa05a7c8
2001214776ANDAPharmaceutical Associates, Inc.2006-07-07MEGESTROL ACETATEORALSUSPENSIONANDA07672132e50ccb-863a-4cd9-8556-7eb22f1c5cff
3498840907ANDAPar Pharmaceutical Companies, Inc.2001-07-25MEGESTROL ACETATEORALSUSPENSIONANDA075671fd97ca46-3f69-440b-80f1-28fed4544f2a
4604320126ANDAMorton Grove Pharmaceuticals, Inc.2005-02-09MEGESTROL ACETATEORALSUSPENSIONANDA076721eea3f3e0-ca3a-4f5d-8185-d52944b67e7a

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1165900898ANDAStat Rx Usa Llc2002-02-15MEGESTROL ACETATEORALSUSPENSION000543542ANDA075997dd332944-d610-4338-9e5e-9b2e5e90e399
2178560907ANDAAtlantic Biologicals Corps2001-07-25MEGESTROL ACETATEORALSUSPENSION498840907ANDA075671239dacec-8c96-4f4d-878a-b9681cb390f3
3548685389ANDAPhysicians Total Care, Inc.2005-09-01MEGESTROL ACETATEORALSUSPENSION498840907ANDA075671160b602d-07bd-46fc-93fe-f89300c6b62f
4551541579ANDACardinal Health2004-02-25MEGESTROL ACETATEORALSUSPENSION680940528ANDA075671f2ea3151-26d7-4647-8dae-de6428bcdd67
5551541582ANDACardinal Health2004-02-25MEGESTROL ACETATEORALSUSPENSION680940528ANDA075671f2ea3151-26d7-4647-8dae-de6428bcdd67
6551541587ANDACardinal Health2014-06-23MEGESTROL ACETATEORALSUSPENSION680940250ANDA075671f27ed1b7-09fb-4ebd-93c4-04d5def13d4c
7551549440ANDACardinal Health2006-07-07MEGESTROL ACETATEORALSUSPENSION001214776ANDA0767215010af22-b449-495a-9992-4c92232170db
8637390549ANDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2013-03-08MEGESTROL ACETATEORALSUSPENSION498840907ANDA07567195dfc24a-5744-4ddf-8809-86184142a372
9666890020ANDAVistapharm Inc.2012-08-22MEGESTROL ACETATEORALSUSPENSION498840907ANDA075671ad17ca75-427d-426c-9813-040eb9729612
10680940250ANDAPrecision Dose Inc.2014-06-23MEGESTROL ACETATEORALSUSPENSION498840907ANDA0756716bbc31b1-927a-48ea-a85a-09de833d2207
11680940361ANDAPrecision Dose Inc.2014-10-08MEGESTROL ACETATEORALSUSPENSION498840907ANDA07567165cd51ce-b81a-4633-b80c-951cba788422
12680940518ANDAPrecision Dose Inc.2007-01-09MEGESTROL ACETATEORALSUSPENSION498840907ANDA075671ec390cca-f69e-451b-8694-9516ee4c983b
13680940528ANDAPrecision Dose Inc.2004-02-25MEGESTROL ACETATEORALSUSPENSION498840907ANDA075671ec390cca-f69e-451b-8694-9516ee4c983b

application(s)

#idtitledeprecatedapplicantapprovedpatentapproved drug
1ANDA075671MEGESTROL ACETATEPAR PHARMACEUTICAL INC2001-07-25ANDA075671_001
2ANDA075681MEGESTROL ACETATETEVA PHARMACEUTICALS USA2003-05-05ANDA075681_001
3ANDA075997MEGESTROL ACETATEROXANE LABORATORIES INC2002-02-15ANDA075997_001
4ANDA076721MEGESTROL ACETATEWOCKHARDT EU OPERATIONS (SWISS) AG2004-11-01ANDA076721_001
5ANDA077404MEGESTROL ACETATETrueAPOTEX INC2006-02-16ANDA077404_001
6ANDA203139MEGESTROL ACETATETWI PHARMACEUTICALS INC2014-08-27ANDA203139_001
7NDA020264MEGACEBRISTOL MYERS SQUIBB1993-09-10NDA020264_001
8NDA021778MEGACE ESPAR PHARMACEUTICAL INC2005-07-05p9101540, TREATMENT OF ANOREXIA, SUBSTANCE
p7101576, TREATMENT OF ANOREXIA
p9101549, TREATMENT OF ANOREXIA
p9040088, TREATMENT OF ANOREXIA
p6592903, SUBSTANCE
p9107827, TREATMENT OF ANOREXIA
NDA021778_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA075671_001RXMEGESTROL ACETATE (40MG/ML)ORALSUSPENSIONFalseAB2001-07-25MEGESTROL ACETATE
2ANDA075681_001RXMEGESTROL ACETATE (40MG/ML)ORALSUSPENSIONFalseAB2003-05-05MEGESTROL ACETATE
3ANDA075997_001RXMEGESTROL ACETATE (40MG/ML)ORALSUSPENSIONFalseAB2002-02-15MEGESTROL ACETATE
4ANDA076721_001RXMEGESTROL ACETATE (40MG/ML)ORALSUSPENSIONFalseAB2004-11-01MEGESTROL ACETATE
5ANDA077404_001discontinuedMEGESTROL ACETATE (40MG/ML)ORALSUSPENSIONFalse2006-02-16MEGESTROL ACETATE
6ANDA203139_001RXMEGESTROL ACETATE (125MG/ML)ORALSUSPENSIONFalseAB2014-08-27MEGESTROL ACETATE
7NDA020264_001RXMEGESTROL ACETATE (40MG/ML)ORALSUSPENSIONTrueAB1993-09-10MEGACE
8NDA021778_001RXMEGESTROL ACETATE (125MG/ML)ORALSUSPENSIONTrueAB2005-07-05MEGACE ES

patent(s)

#idexpiration dateapplication(s)
1p6592903 (view patent)2020-09-21NDA021778
2p7101576 (view patent)2024-04-22NDA021778
3p9040088 (view patent)2024-04-22NDA021778
4p9101540 (view patent)2024-04-22NDA021778
5p9101549 (view patent)2024-04-22NDA021778
6p9107827 (view patent)2024-04-22NDA021778

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1160b602d-07bd-46fc-93fe-f89300c6b62f (view SPL)MEGESTROL ACETATE ORAL SUSPENSIONprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-11-241548685389
2239dacec-8c96-4f4d-878a-b9681cb390f3 (view SPL)prescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2011-07-274178560907
32bd8c04f-491c-4269-9281-642efa05a7c8 (view SPL)Megestrol Acetate Oral Suspension USP, 40 mg/mLprescriptionHuman PrescriptionRoxane Laboratories, IncMANUFACTURE2015-10-016000543542
42dc921d5-e423-4379-a345-151e87d13651 (view SPL)These highlights do not include all the information needed to use MEGESTROL ACETATE ORAL SUSPENSION safely and effectively. See full prescribing information for MEGESTROL ACETATE ORAL SUSPENSION. MEGESTROL ACETATE oral suspension Initial U.S. Approval: 1993prescriptionHuman PrescriptionTwi Pharmaceuticals, Inc.analysis, manufacture, pack2015-07-294249790041
532e50ccb-863a-4cd9-8556-7eb22f1c5cff (view SPL)Megestrol Acetate Oral Suspension USP40 mg/mLprescriptionHuman PrescriptionPharmaceutical Associates, Inc.MANUFACTURE, REPACK2013-12-062001214776
633bc102c-31a3-4fd9-9702-c1193d7699a3 (view SPL)MEGACE ES (megestrol acetate oral suspension) suspensionprescriptionHuman PrescriptionStat Rx Usa Llc2009-10-272165900254
75010af22-b449-495a-9992-4c92232170db (view SPL)Megestrol Acetate Oral Suspension USP40 mg/mLprescriptionHuman PrescriptionCardinal HealthREPACK2015-01-212551549440
8654854bc-f847-4e3b-a0a1-8716553460ac (view SPL)These highlights do not include all the information needed to use Megace ES safely and effectively. See full prescribing information for Megace ES. Megace ES (megestrol acetate, USP) Oral Suspension Initial U.S. Approval: 1993 prescriptionHuman PrescriptionAtlantic Biologicals CorpsRELABEL, REPACK2014-03-183178560949
965b28775-ee59-88cf-e4d8-372c6c79ad14 (view SPL)Megace (megestrol acetate, USP)Oral SuspensionprescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2015-05-296000150508
1065cd51ce-b81a-4633-b80c-951cba788422 (view SPL)MEGESTROL ACETATE ORAL SUSPENSION, USP 400 mg per 10 mL - 800 mg per 20 mLprescriptionHuman PrescriptionPrecision Dose Inc.2014-12-041680940361
116bbc31b1-927a-48ea-a85a-09de833d2207 (view SPL)MEGESTROL ACETATE ORAL SUSPENSION, USP400 mg per 10 mL - 800 mg per 20 mLprescriptionHuman PrescriptionPrecision Dose Inc.2014-07-161680940250
129439c3c2-338a-4d5a-be71-62c71e255504 (view SPL)These highlights do not include all the information needed to use Megestrol Acetate Oral Suspension safely and effectively. See full prescribing information for Megestrol Acetate Oral Suspension.Initial U.S. Approval: 1993prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2015-07-281498840230
1395dfc24a-5744-4ddf-8809-86184142a372 (view SPL)Megestrol Acetate Suspension40mg/mL Rx OnlyRevised 7/11prescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationREPACK2013-03-012637390549
14ad17ca75-427d-426c-9813-040eb9729612 (view SPL)Vista Pharm MEGESTROL ACETATE ORAL SUSPENSION 40 mg/mLprescriptionHuman PrescriptionVistapharm Inc.ANALYSIS, REPACK2012-08-282666890020
15dd332944-d610-4338-9e5e-9b2e5e90e399 (view SPL)prescriptionHuman PrescriptionStat Rx Usa Llc2010-01-221165900898
16e3e96f8d-31a6-4457-8e05-02579b539b8a (view SPL)These highlights do not include all the information needed to use Megace ES safely and effectively. See full prescribing information for Megace ES. Megace ES (megestrol acetate) Oral Suspension Initial U.S. Approval: 1993prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-03-301548685572
17ec390cca-f69e-451b-8694-9516ee4c983b (view SPL)MEGESTROL ACETATE ORAL SUSPENSIONprescriptionHuman PrescriptionPrecision Dose Inc.2012-02-172680940518, 680940528
18eea3f3e0-ca3a-4f5d-8185-d52944b67e7a (view SPL)MEGESTROL ACETATEORAL SUSPENSION, USP40 mg/mLprescriptionHuman PrescriptionMorton Grove Pharmaceuticals, Inc.2014-01-094604320126
19f27ed1b7-09fb-4ebd-93c4-04d5def13d4c (view SPL)MEGESTROL ACETATE ORAL SUSPENSION, USP 400 mg per 10 mL - 800 mg per 20 mLprescriptionHuman PrescriptionCardinal HealthREPACK2015-04-201551541587
20f2ea3151-26d7-4647-8dae-de6428bcdd67 (view SPL)MEGESTROL ACETATE ORAL SUSPENSIONprescriptionHuman PrescriptionCardinal HealthREPACK2012-05-023551541579, 551541582
21f5525acb-a982-45e8-8265-a7d7a7974141 (view SPL)These highlights do not include all the information needed to use Megace ES safely and effectively. See full prescribing information for Megace ES. Megace ES (megestrol acetate, USP) Oral SuspensionInitial U.S. Approval: 1993prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.MANUFACTURE2014-03-1810498840949
22fd97ca46-3f69-440b-80f1-28fed4544f2a (view SPL)prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.2012-11-285498840907

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