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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202691
Company: HIKMA

Products on ANDA 202691

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202691

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.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/23/2019	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
12/23/2019	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202691

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	202691	HIKMA
METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	040888	SAGENT PHARMS INC
METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 500MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	212396	TIANJIN KINGYORK
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 INC
METHYLPREDNISOLONE SODIUM SUCCINATE	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	212396	TIANJIN KINGYORK
SOLU-MEDROL	METHYLPREDNISOLONE SODIUM SUCCINATE	EQ 1GM BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	011856	PHARMACIA AND UPJOHN

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