Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217791
Company: SOMERSET

Products on ANDA 217791

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ATROPINE SULFATE	ATROPINE SULFATE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217791

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2024	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/217791Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 217791

ATROPINE SULFATE

SOLUTION/DROPS;OPHTHALMIC; 1%
TE Code = AT2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ATROPINE SULFATE	ATROPINE SULFATE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	217791	SOMERSET
ISOPTO ATROPINE	ATROPINE SULFATE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT2	208151	ALCON LABS INC