Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217227
Company: SOMERSET THERAPS LLC

Products on ANDA 217227

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TETRACAINE HYDROCHLORIDE	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION;OPHTHALMIC	Prescription	AB1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217227

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217227Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 217227

TETRACAINE HYDROCHLORIDE

SOLUTION;OPHTHALMIC; 0.5%
TE Code = AB1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TETRACAINE HYDROCHLORIDE	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION;OPHTHALMIC	Prescription	Yes	AB1	210821	BAUSCH LOMB IRELAND
TETRACAINE HYDROCHLORIDE	TETRACAINE HYDROCHLORIDE	0.5%	SOLUTION;OPHTHALMIC	Prescription	No	AB1	217227	SOMERSET THERAPS LLC