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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040583
Company: FRESENIUS KABI USA

Products on ANDA 040583

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040583

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
02/07/2023	SUPPL-12	Labeling-Package Insert		Label is not available on this site.
08/06/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
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.

Therapeutic Equivalents for ANDA 040583

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
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	203125	HIKMA
METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040888	SAGENT PHARMS INC
METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 40MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	212396	TIANJIN KINGYORK
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
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	203125	HIKMA
METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040888	SAGENT PHARMS INC
METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	212396	TIANJIN KINGYORK
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 125MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	011856	PHARMACIA AND UPJOHN

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