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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219856
Company: APOTEX

Products on ANDA 219856

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE SODIUM SUCCINATE	HYDROCORTISONE SODIUM SUCCINATE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219856

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/05/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219856

HYDROCORTISONE SODIUM SUCCINATE

INJECTABLE;INJECTION; EQ 100MG BASE/VIAL
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCORTISONE SODIUM SUCCINATE	HYDROCORTISONE SODIUM SUCCINATE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	219856	APOTEX
HYDROCORTISONE SODIUM SUCCINATE	HYDROCORTISONE SODIUM SUCCINATE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	No	AP	214050	CIPLA
SOLU-CORTEF	HYDROCORTISONE SODIUM SUCCINATE	EQ 100MG BASE/VIAL	INJECTABLE;INJECTION	Prescription	Yes	AP	009866	PHARMACIA AND UPJOHN

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