Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202691
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/16/2016 ORIG-1 Approval

Label is not available on this site.

METHYLPREDNISOLONE SODIUM SUCCINATE

INJECTABLE;INJECTION; EQ 500MG BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207667 AUROBINDO PHARMA LTD
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202691 HIKMA
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040888 SAGENT PHARMS
SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 011856 PHARMACIA AND UPJOHN

INJECTABLE;INJECTION; EQ 1GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040612 FRESENIUS KABI USA
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202691 HIKMA
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040888 SAGENT PHARMS
SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 011856 PHARMACIA AND UPJOHN

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