Methylprednisolone Injectable Suspension

Brand(s)
Depo-Medrol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Pharmacia And Upjohn Company (2014-08-05)
Oldest Current Product
1959-05-28
License(s)
NDA, ANDA
RxNORM
INJECTABLE SUSPENSION\METHYLPREDNISOLONE
FDAOB
INJECTION\INJECTION\METHYLPREDNISOLONE ACETATE\rdfq
SPL Active
INTRA-ARTICULAR\INJECTION, SUSPENSION\METHYLPREDNISOLONE ACETATE
INTRALESIONAL\INJECTION, SUSPENSION\METHYLPREDNISOLONE ACETATE
INTRAMUSCULAR\INJECTION, SUSPENSION\METHYLPREDNISOLONE ACETATE
INTRAMUSCULAR\INJECTION\METHYLPREDNISOLONE ACETATE
SPL Moiety
INTRA-ARTICULAR\INJECTION, SUSPENSION\METHYLPREDNISOLONE
INTRALESIONAL\INJECTION, SUSPENSION\METHYLPREDNISOLONE
INTRAMUSCULAR\INJECTION, SUSPENSION\METHYLPREDNISOLONE
INTRAMUSCULAR\INJECTION\METHYLPREDNISOLONE

product(s) by strength(s)

methylprednisolone acetate 20 mg/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090274Depo-MedrolNDAPharmacia And Upjohn Company1959-05-28METHYLPREDNISOLONE ACETATEINTRALESIONALINJECTION, SUSPENSIONNDA011757823b0010-2b57-4e76-b5ac-4a8c2963438f

methylprednisolone acetate 40 mg/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000093073Depo-MedrolNDAPharmacia And Upjohn Company1959-05-28METHYLPREDNISOLONE ACETATEINTRA-ARTICULARINJECTION, SUSPENSIONNDA0117579a7b3837-e038-48bf-97e9-78ad463760dc, bf1b104d-85cb-414d-a366-78068c82c883

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007030031ANDATeva Parenteral Medicines, Inc2005-03-08METHYLPREDNISOLONE ACETATEINTRAMUSCULARINJECTION, SUSPENSIONANDA040557978b8416-2e88-4816-8a37-bb20b9af4b1d
2007030043ANDATeva Parenteral Medicines, Inc2006-10-31METHYLPREDNISOLONE ACETATEINTRAMUSCULARINJECTIONANDA040620769cc1ae-bdf4-47e4-9a9f-c6327bd7dbf4
3007030045ANDATeva Parenteral Medicines, Inc2006-10-31METHYLPREDNISOLONE ACETATEINTRALESIONALINJECTION, SUSPENSIONANDA040620769cc1ae-bdf4-47e4-9a9f-c6327bd7dbf4
4007813131ANDASandoz Inc2009-03-05METHYLPREDNISOLONE ACETATEINTRA-ARTICULARINJECTION, SUSPENSIONANDA04079448f9697a-7068-4b3c-9a32-f38fa8e80077
5007813136ANDASandoz Inc2009-01-29METHYLPREDNISOLONE ACETATEINTRA-ARTICULARINJECTION, SUSPENSIONANDA04071951acea4c-540f-4c65-80c6-4b0a7ba041b9

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950849ANDARebel Distributors Corp2009-03-05METHYLPREDNISOLONE ACETATEINTRA-ARTICULARINJECTION, SUSPENSION007813131ANDA040794faf608f3-a13d-4969-b1a6-bb0bc1de2a8e
2216950952Depo-MedrolNDARebel Distributors Corp1959-05-28METHYLPREDNISOLONE ACETATEINTRALESIONALINJECTION, SUSPENSION000090280NDA01175741fa78f5-8f41-415e-80f3-7fee7091df5e
3493490755Depo-MedrolNDARemedyrepack Inc.2013-06-11, 2015-05-18METHYLPREDNISOLONE ACETATEINTRAMUSCULARINJECTION, SUSPENSION000090280NDA011757242ef48a-e32b-4dc0-b38e-695609259115, e5c1a338-3d2f-409e-a705-55c2f76be7a1
4493490948Depo-MedrolNDARemedyrepack Inc.2013-04-10METHYLPREDNISOLONE ACETATEINTRAMUSCULARINJECTION, SUSPENSION000093073NDA0117573684398d-4df6-4e42-bfa0-1cc78b59f7ee
5548680590ANDAPhysicians Total Care, Inc.2012-07-26METHYLPREDNISOLONE ACETATEINTRAMUSCULARINJECTION, SUSPENSION007030031ANDA040557369e030c-1ea4-4104-885c-a60d6cedf072
6551543929Depo-MedrolNDACardinal Health1959-05-28METHYLPREDNISOLONE ACETATEINTRA-ARTICULARINJECTION, SUSPENSION000093073NDA011757ccb4d123-7b12-4aef-8ef0-f8d68c1a6547
7631870474ANDAProficient Rx Lp2005-03-08METHYLPREDNISOLONE ACETATEINTRA-ARTICULARINJECTION, SUSPENSION007030031ANDA040557397cad9e-ab18-4271-8a17-9387c2358c49

methylprednisolone acetate 80 mg/ml injectable suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000090306Depo-MedrolNDAPharmacia And Upjohn Company1959-05-28METHYLPREDNISOLONE ACETATEINTRALESIONALINJECTION, SUSPENSIONNDA011757823b0010-2b57-4e76-b5ac-4a8c2963438f, cb33bed8-6f99-4a00-aa3a-c74e4f0a17e7

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1007030051ANDATeva Parenteral Medicines, Inc2005-03-08METHYLPREDNISOLONE ACETATEINTRAMUSCULARINJECTION, SUSPENSIONANDA040557978b8416-2e88-4816-8a37-bb20b9af4b1d
2007030063ANDATeva Parenteral Medicines, Inc2006-10-31METHYLPREDNISOLONE ACETATEINTRALESIONALINJECTION, SUSPENSIONANDA040620769cc1ae-bdf4-47e4-9a9f-c6327bd7dbf4
3007813132ANDASandoz Inc2009-03-05METHYLPREDNISOLONE ACETATEINTRA-ARTICULARINJECTION, SUSPENSIONANDA04079448f9697a-7068-4b3c-9a32-f38fa8e80077
4007813137ANDASandoz Inc2009-01-29METHYLPREDNISOLONE ACETATEINTRA-ARTICULARINJECTION, SUSPENSIONANDA04071951acea4c-540f-4c65-80c6-4b0a7ba041b9

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950850ANDARebel Distributors Corp2009-03-05METHYLPREDNISOLONE ACETATEINTRA-ARTICULARINJECTION, SUSPENSION007813132ANDA040794faf608f3-a13d-4969-b1a6-bb0bc1de2a8e
2550453243Depo-MedrolNDADispensing Solutions, Inc.1959-05-28METHYLPREDNISOLONE ACETATEINTRALESIONALINJECTION, SUSPENSION000090306NDA011757c5ca262e-5558-4065-8ef5-e2e76f3635e5
3551543932Depo-MedrolNDACardinal Health1959-05-28METHYLPREDNISOLONE ACETATEINTRA-ARTICULARINJECTION, SUSPENSION000093475NDA011757ccb4d123-7b12-4aef-8ef0-f8d68c1a6547
4617860027Depo-MedrolNDARemedyrepack Inc.2014-09-12METHYLPREDNISOLONE ACETATEINTRAMUSCULARINJECTION, SUSPENSION000090306NDA0117579ac89740-8d4f-4d37-be69-df986d9da69f

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA040557METHYLPREDNISOLONE ACETATETEVA PHARMACEUTICALS USA2005-02-23ANDA040557_001, ANDA040557_002
2ANDA040620METHYLPREDNISOLONE ACETATETEVA PHARMACEUTICALS USA2006-10-27ANDA040620_001, ANDA040620_002
3ANDA040719METHYLPREDNISOLONE ACETATESANDOZ CANADA INC2009-01-29ANDA040719_001, ANDA040719_002
4ANDA040794METHYLPREDNISOLONE ACETATESANDOZ CANADA INC2009-03-05ANDA040794_001, ANDA040794_002
5ANDA085374METHYLPREDNISOLONE ACETATETrueWATSON LABORATORIES INCANDA085374_001
6ANDA085595METHYLPREDNISOLONE ACETATETrueWATSON LABORATORIES INCANDA085595_001
7ANDA085597METHYLPREDNISOLONE ACETATETrueWATSON LABORATORIES INCANDA085597_001
8ANDA085600METHYLPREDNISOLONE ACETATETrueWATSON LABORATORIES INCANDA085600_001
9ANDA086507METHYLPREDNISOLONE ACETATETrueWATSON LABORATORIES INCANDA086507_001
10ANDA086666M-PREDROLTrueBEL MAR LABORATORIES INCANDA086666_001
11ANDA086903METHYLPREDNISOLONE ACETATETrueAKORN INC1982-10-20ANDA086903_001, ANDA086903_002
12ANDA087135M-PREDROLTrueBEL MAR LABORATORIES INCANDA087135_001
13ANDA087248METHYLPREDNISOLONE ACETATETrueWATSON LABORATORIES INCANDA087248_001
14NDA011757DEPO-MEDROLPHARMACIA AND UPJOHN CONDA011757_001, NDA011757_002, NDA011757_004

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA040557_001RXMETHYLPREDNISOLONE ACETATE (40MG/ML)INJECTIONFalseAB2005-02-23METHYLPREDNISOLONE ACETATE
2ANDA040557_002RXMETHYLPREDNISOLONE ACETATE (80MG/ML)INJECTIONFalseAB2005-02-23METHYLPREDNISOLONE ACETATE
3ANDA040620_001RXMETHYLPREDNISOLONE ACETATE (40MG/ML)INJECTIONFalseAB2006-10-27METHYLPREDNISOLONE ACETATE
4ANDA040620_002RXMETHYLPREDNISOLONE ACETATE (80MG/ML)INJECTIONFalseAB2006-10-27METHYLPREDNISOLONE ACETATE
5ANDA040719_001RXMETHYLPREDNISOLONE ACETATE (40MG/ML)INJECTIONFalseAB2009-01-29METHYLPREDNISOLONE ACETATE
6ANDA040719_002RXMETHYLPREDNISOLONE ACETATE (80MG/ML)INJECTIONFalseAB2009-01-29METHYLPREDNISOLONE ACETATE
7ANDA040794_001RXMETHYLPREDNISOLONE ACETATE (40MG/ML)INJECTIONFalseAB2009-03-05METHYLPREDNISOLONE ACETATE
8ANDA040794_002RXMETHYLPREDNISOLONE ACETATE (80MG/ML)INJECTIONFalseAB2009-03-05METHYLPREDNISOLONE ACETATE
9ANDA085374_001discontinuedMETHYLPREDNISOLONE ACETATE (40MG/ML)INJECTIONFalseMETHYLPREDNISOLONE ACETATE
10ANDA085595_001discontinuedMETHYLPREDNISOLONE ACETATE (80MG/ML)INJECTIONFalseMETHYLPREDNISOLONE ACETATE
11ANDA085597_001discontinuedMETHYLPREDNISOLONE ACETATE (20MG/ML)INJECTIONFalseMETHYLPREDNISOLONE ACETATE
12ANDA085600_001discontinuedMETHYLPREDNISOLONE ACETATE (40MG/ML)INJECTIONFalseMETHYLPREDNISOLONE ACETATE
13ANDA086507_001discontinuedMETHYLPREDNISOLONE ACETATE (80MG/ML)INJECTIONFalseMETHYLPREDNISOLONE ACETATE
14ANDA086666_001discontinuedMETHYLPREDNISOLONE ACETATE (40MG/ML)INJECTIONFalseM-PREDROL
15ANDA086903_001discontinuedMETHYLPREDNISOLONE ACETATE (40MG/ML)INJECTIONFalse1982-10-20METHYLPREDNISOLONE ACETATE
16ANDA086903_002discontinuedMETHYLPREDNISOLONE ACETATE (80MG/ML)INJECTIONFalse1982-10-20METHYLPREDNISOLONE ACETATE
17ANDA087135_001discontinuedMETHYLPREDNISOLONE ACETATE (80MG/ML)INJECTIONFalseM-PREDROL
18ANDA087248_001discontinuedMETHYLPREDNISOLONE ACETATE (20MG/ML)INJECTIONFalseMETHYLPREDNISOLONE ACETATE
19NDA011757_001RXMETHYLPREDNISOLONE ACETATE (40MG/ML)INJECTIONTrueABDEPO-MEDROL
20NDA011757_002RXMETHYLPREDNISOLONE ACETATE (20MG/ML)INJECTIONTrueDEPO-MEDROL
21NDA011757_004RXMETHYLPREDNISOLONE ACETATE (80MG/ML)INJECTIONTrueABDEPO-MEDROL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1242ef48a-e32b-4dc0-b38e-695609259115 (view SPL)DEPO-MEDROL methylprednisolone acetate injectable suspension, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-111493490755
23684398d-4df6-4e42-bfa0-1cc78b59f7ee (view SPL)DEPO-MEDROLmethylprednisolone acetate injectable suspension, USPprescriptionHuman PrescriptionRemedyrepack Inc.2013-04-101493490948
3369e030c-1ea4-4104-885c-a60d6cedf072 (view SPL)MethylPREDNISolone ACETATE Injectable Suspension USPprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-08-291548680590
4397cad9e-ab18-4271-8a17-9387c2358c49 (view SPL)MethylPREDNISolone ACETATE Injectable Suspension USPprescriptionHuman PrescriptionProficient Rx LpRELABEL, REPACK2015-02-011631870474
541fa78f5-8f41-415e-80f3-7fee7091df5e (view SPL)DEPO-MEDROL methylprednisolone acetate injectable suspension, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-06-281216950952
648f9697a-7068-4b3c-9a32-f38fa8e80077 (view SPL)MethylPREDNISolone Acetate Injectable Suspension, USPprescriptionHuman PrescriptionSandoz Inc2011-10-2012007813131, 007813132
751acea4c-540f-4c65-80c6-4b0a7ba041b9 (view SPL)MethylPREDNISolone Acetate Injectable Suspension, USPprescriptionHuman PrescriptionSandoz Inc2013-03-1811007813136, 007813137
8769cc1ae-bdf4-47e4-9a9f-c6327bd7dbf4 (view SPL)Methylprednisolone Acetate Injectable Suspension USPprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2014-09-085007030043, 007030045, 007030063
9823b0010-2b57-4e76-b5ac-4a8c2963438f (view SPL)DEPO-MEDROL (methylprednisolone acetate injectable suspension, USP)prescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2014-07-106000090274, 000090306, 000090280
10978b8416-2e88-4816-8a37-bb20b9af4b1d (view SPL)MethylPREDNISolone ACETATE Injectable Suspension USPprescriptionHuman PrescriptionTeva Parenteral Medicines, Inc2014-09-046007030031, 007030051
119a7b3837-e038-48bf-97e9-78ad463760dc (view SPL)DEPO-MEDROL (methylprednisolone acetate injectable suspension, USP)prescriptionHuman PrescriptionPharmacia And Upjohn CompanyAPI MANUFACTURE, MANUFACTURE, PACK2014-07-1012000093073, 000093475
129ac89740-8d4f-4d37-be69-df986d9da69f (view SPL)DEPO-MEDROL (methylprednisolone acetate injectable suspension, USP)prescriptionHuman PrescriptionRemedyrepack Inc.2014-09-121617860027
13bf1b104d-85cb-414d-a366-78068c82c883 (view SPL)DEPO-MEDROL (methylprednisolone acetate injectable suspension, USP)prescriptionHuman PrescriptionPharmacia And Upjohn CompanyANALYSIS, API MANUFACTURE, MANUFACTURE2014-08-053000093073, 000093475
14c5ca262e-5558-4065-8ef5-e2e76f3635e5 (view SPL)DEPO-MEDROL methylprednisolone acetate injectable suspension, USPprescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-02-011550453243
15cb33bed8-6f99-4a00-aa3a-c74e4f0a17e7 (view SPL)DEPO-MEDROL methylprednisolone acetate injectable suspension, USPprescriptionHuman PrescriptionPharmacia And Upjohn CompanyAPI MANUFACTURE, MANUFACTURE, PACK2014-01-286000090306, 000090280
16ccb4d123-7b12-4aef-8ef0-f8d68c1a6547 (view SPL)DEPO-MEDROL (methylprednisolone acetate injectable suspension, USP)prescriptionHuman PrescriptionCardinal HealthREPACK2014-10-225551543929, 551543932
17e5c1a338-3d2f-409e-a705-55c2f76be7a1 (view SPL)DEPO-MEDROL (methylprednisolone acetate injectable suspension, USP)prescriptionHuman PrescriptionRemedyrepack Inc.2015-05-181493490755
18faf608f3-a13d-4969-b1a6-bb0bc1de2a8e (view SPL)MethylPREDNISolone Acetate Injectable Suspension, USPprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-01-171216950849, 216950850

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