Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217597
Company: ALEMBIC

Products on ANDA 217597

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LOTEPREDNOL ETABONATE AND TOBRAMYCIN	LOTEPREDNOL ETABONATE; TOBRAMYCIN	0.5%;0.3%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217597

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/10/2025	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217597Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 217597

LOTEPREDNOL ETABONATE AND TOBRAMYCIN

SUSPENSION/DROPS;OPHTHALMIC; 0.5%;0.3%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
LOTEPREDNOL ETABONATE AND TOBRAMYCIN	LOTEPREDNOL ETABONATE; TOBRAMYCIN	0.5%;0.3%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	No	AB	217597	ALEMBIC
ZYLET	LOTEPREDNOL ETABONATE; TOBRAMYCIN	0.5%;0.3%	SUSPENSION/DROPS;OPHTHALMIC	Prescription	Yes	AB	050804	BAUSCH AND LOMB