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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209040
Company: SANDOZ

Products on ANDA 209040

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 209040

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/28/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209040Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 209040

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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