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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207524
Company: SOMERSET THERAPS LLC

Products on ANDA 207524

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207524

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/12/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 207524

TROPICAMIDE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MYDRIACYL	TROPICAMIDE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	084306	ALCON LABS INC
TROPICACYL	TROPICAMIDE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	040315	RISING
TROPICAMIDE	TROPICAMIDE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	040064	BAUSCH AND LOMB
TROPICAMIDE	TROPICAMIDE	1%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	207524	SOMERSET THERAPS LLC

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