An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207549
Company: AMNEAL

Products on ANDA 207549

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 207549

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/09/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207549Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/207549Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/21/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/21/2020	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Labels for ANDA 207549

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/09/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/207549Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 207549

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

Top