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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218002
Company: INGENUS PHARMS LLC

Products on ANDA 218002

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TAFLUPROST	TAFLUPROST	0.0015%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218002

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/05/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218002

TAFLUPROST

SOLUTION/DROPS;OPHTHALMIC; 0.0015%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TAFLUPROST	TAFLUPROST	0.0015%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	218002	INGENUS PHARMS LLC
TAFLUPROST	TAFLUPROST	0.0015%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	209051	MICRO LABS
TAFLUPROST	TAFLUPROST	0.0015%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	209040	SANDOZ
ZIOPTAN	TAFLUPROST	0.0015%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	202514	THEA PHARMA

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