Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040583
Company: FRESENIUS KABI USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE;INJECTION Prescription AP No No
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG 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
07/30/2004 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/40583ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/040583_ORIGINAL APPROVAL_PACKAGE.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/13/2015 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

04/13/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

METHYLPREDNISOLONE SODIUM SUCCINATE

INJECTABLE;INJECTION; EQ 40MG 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 40MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207549 AMNEAL PHARMS CO
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207667 AUROBINDO PHARMA LTD
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040583 FRESENIUS KABI USA
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040888 SAGENT PHARMS
SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 011856 PHARMACIA AND UPJOHN

INJECTABLE;INJECTION; EQ 125MG 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 125MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207549 AMNEAL PHARMS CO
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 207667 AUROBINDO PHARMA LTD
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040583 FRESENIUS KABI USA
METHYLPREDNISOLONE SODIUM SUCCINATE METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE;INJECTION Prescription No AP 040888 SAGENT PHARMS
SOLU-MEDROL METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 011856 PHARMACIA AND UPJOHN

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