FDA.reportPublic FDA data

Application 011757

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEPO-MEDROLMETHYLPREDNISOLONE ACETATEINJECTABLE;INJECTION40MG/MLYesYes
002DEPO-MEDROLMETHYLPREDNISOLONE ACETATEINJECTABLE;INJECTION20MG/MLYesYes
004DEPO-MEDROLMETHYLPREDNISOLONE ACETATEINJECTABLE;INJECTION80MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0009-0274Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-0274Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-0274Depo-Medrolmethylprednisolone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0274Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-0280Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-0280Depo-Medrolmethylprednisolone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0280Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-0280Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-0280Depo-Medrolmethylprednisolone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0306Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-0306Depo-Medrolmethylprednisolone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-0306Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-0306Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-0306Depo-Medrolmethylprednisolone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-3073Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-3073Depo-Medrolmethylprednisolone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-3073Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-3073Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-3073Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-3073Depo-Medrolmethylprednisolone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-3073Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-3073Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-3475Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-3475Depo-Medrolmethylprednisolone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-3475Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-3475Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-3475Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-3475Depo-Medrolmethylprednisolone acetatePharmacia and Upjohn Company LLCNDACurrent
0009-3475Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
0009-3475Depo-Medrolmethylprednisolone acetatePharmacia & Upjohn Company LLCNDACurrent
21695-952Depo-Medrolmethylprednisolone acetateRebel Distributors CorpNDACurrent
49836-010P-Care D40MXMethylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HClRX PHARMA-PACK, INC.NDACurrent
49836-010P-Care D40MXMethylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HClRX PHARMA-PACK, INC.NDACurrent
49836-010P-Care D40MXMethylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HClRX PHARMA-PACK, INC.NDACurrent
49836-011P-Care D40methylprednisolone acetate, povidone-iodine, isopropyl alcoholRX PHARMA-PACK, INC.NDACurrent
49836-011P-Care D40methylprednisolone acetate, povidone-iodine, isopropyl alcoholRX PHARMA-PACK, INC.NDACurrent
49836-011P-Care D40methylprednisolone acetate, povidone-iodine, isopropyl alcoholRX PHARMA-PACK, INC.NDACurrent
49836-012P-Care D40GMethylprednisolone Acetate, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-012P-Care D40GMethylprednisolone Acetate, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-012P-Care D40GMethylprednisolone Acetate, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-013P-Care D80MXMethylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HClRX PHARMA-PACK, INC.NDACurrent
49836-013P-Care D80MXMethylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HClRX PHARMA-PACK, INC.NDACurrent
49836-013P-Care D80MXMethylprednisolone Acetate, Povidone-Iodine, Isopropyl Alcohol, Bupivacaine HCl, Sodium Chloride, Lidocaine HClRX PHARMA-PACK, INC.NDACurrent
49836-014P-Care D80Methylprednisolone Acetate, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-014P-Care D80Methylprednisolone Acetate, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-014P-Care D80Methylprednisolone Acetate, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-015P-Care D80GMethylprednisolone Acetate, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-015P-Care D80GMethylprednisolone Acetate, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
49836-015P-Care D80GMethylprednisolone Acetate, Povidone-Iodine, Isopropyl AlcoholRX PHARMA-PACK, INC.NDACurrent
50090-0312Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-0312Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-0312Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-0436Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-0436Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-0436Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-0556Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-0556Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-0556Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-1823Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-1823Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-1823Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-2098Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-2098Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-2098Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
50090-2098Depo-Medrolmethylprednisolone acetateA-S Medication SolutionsNDACurrent
55045-3243Depo-Medrolmethylprednisolone acetateDispensing Solutions, Inc.NDACurrent
55154-3929Depo-Medrolmethylprednisolone acetateCardinal HealthNDACurrent
55154-3932Depo-Medrolmethylprednisolone acetateCardinal HealthNDACurrent
63187-350Multi-Specialty KitDepo-Medrol, Lidocaine, Isopropyl AlcoholProficient Rx LPNDACurrent
63874-413MethylprednisolonemethylprednisoloneAltura Pharmaceuticals, Inc.NDACurrent
70518-0516Depo-Medrolmethylprednisolone acetateREMEDYREPACK INC.NDACurrent
70518-0516Depo-Medrolmethylprednisolone acetateREMEDYREPACK INC.NDACurrent
70518-0516Depo-Medrolmethylprednisolone acetateREMEDYREPACK INC.NDACurrent
70518-0516Depo-Medrolmethylprednisolone acetateREMEDYREPACK INC.NDACurrent
70518-1088Depo-Medrolmethylprednisolone acetateREMEDYREPACK INC.NDACurrent
70518-2148Depo-Medrolmethylprednisolone acetateREMEDYREPACK INC.NDACurrent
70518-2148Depo-Medrolmethylprednisolone acetateREMEDYREPACK INC.NDACurrent
70518-2148Depo-Medrolmethylprednisolone acetateREMEDYREPACK INC.NDACurrent
70518-2148Depo-Medrolmethylprednisolone acetateREMEDYREPACK INC.NDACurrent
70859-037Point Of Care L2Depo-Medrol, Lidocaine HCI, Isopropyl AlcoholNuCare Pharmaceuticals,Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84123SUPPL 2025-11-07
84067SUPPL 2025-11-05
78707SUPPL 2024-06-07
78674SUPPL 2024-06-06
77122SUPPL 2023-12-22
77104SUPPL 2023-12-21
67702SUPPL2021-06-04
67629SUPPL2021-05-28
66223SUPPL2021-02-16
66208SUPPL2021-02-16
64124SUPPL2020-07-29
54997SUPPL2018-07-26
54964SUPPL2018-07-25
47598SUPPL2017-03-20
45261SUPPL2016-09-09
45251SUPPL2016-09-09
10778SUPPL2014-07-09
285SUPPL2014-07-08
33055SUPPL2009-04-16
11958SUPPL2009-04-16
11957SUPPL2009-04-16
10777SUPPL2009-04-16