Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077838
Company: HIKMA

Products on ANDA 077838

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE	BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE	3MG/ML;EQ 3MG BASE/ML	INJECTABLE;INJECTION	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077838

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/17/2023	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
03/28/2025	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077838

BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE

INJECTABLE;INJECTION; 3MG/ML;EQ 3MG BASE/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE	BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE	3MG/ML;EQ 3MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AB	090747	AM REGENT
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE	BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE	3MG/ML;EQ 3MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AB	077838	HIKMA
CELESTONE SOLUSPAN	BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE	3MG/ML;EQ 3MG BASE/ML	INJECTABLE;INJECTION	Prescription	Yes	AB	014602	ORGANON