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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040314
Company: EPIC PHARMA LLC

Products on ANDA 040314

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TROPICACYL	TROPICAMIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 040314

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/29/2000	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/25/2012	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
06/29/2001	SUPPL-1	Manufacturing (CMC)-Facility		Label is not available on this site.

Therapeutic Equivalents for ANDA 040314

TROPICACYL

SOLUTION/DROPS;OPHTHALMIC; 0.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MYDRIACYL	TROPICAMIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	084305	SANDOZ
TROPICACYL	TROPICAMIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	040314	EPIC PHARMA LLC
TROPICAMIDE	TROPICAMIDE	0.5%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	040067	BAUSCH AND LOMB

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