Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213956
Company: HIKMA

Products on ANDA 213956

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 213956

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/29/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213956

LOTEPREDNOL ETABONATE

GEL;OPHTHALMIC; 0.5%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOTEMAX	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	Yes	AB	202872	BAUSCH AND LOMB INC
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	No	AB	213956	HIKMA
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	No	AB	212080	SENTISS
LOTEPREDNOL ETABONATE	LOTEPREDNOL ETABONATE	0.5%	GEL;OPHTHALMIC	Prescription	No	AB	215384	SUN PHARM