Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219145
Company: HIKMA

Products on ANDA 219145

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219145

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/16/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219145

METHYLPREDNISOLONE ACETATE

INJECTABLE;INJECTION; 80MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEPO-MEDROL	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	Yes	AB	011757	PFIZER
METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	210043	AMNEAL
METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	216502	AMNEAL
METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	220556	CAPLIN
METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	211930	EUGIA PHARMA
METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	219145	HIKMA
METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	040557	HONG KONG
METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	214297	PH HEALTH
METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	201835	SAGENT PHARMS INC
METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	040719	SANDOZ
METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	040794	SANDOZ
METHYLPREDNISOLONE ACETATE	METHYLPREDNISOLONE ACETATE	80MG/ML	INJECTABLE;INJECTION	Prescription	No	AB	214870	WILSHIRE PHARMS INC