Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203431
Company: APOTEX

Products on ANDA 203431

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TRAVOPROST	TRAVOPROST	0.004%	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203431

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/10/2015	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203431Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2020	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
01/27/2020	SUPPL-5	Labeling-Container/Carton Labels		Label is not available on this site.
01/27/2020	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 203431

TRAVOPROST

SOLUTION/DROPS;OPHTHALMIC; 0.004%
TE Code = AT2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TRAVATAN Z	TRAVOPROST	0.004%	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT2	021994	SANDOZ
TRAVOPROST	TRAVOPROST	0.004%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	214687	ALEMBIC
TRAVOPROST	TRAVOPROST	0.004%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	203431	APOTEX
TRAVOPROST	TRAVOPROST	0.004%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	218159	GLAND
TRAVOPROST	TRAVOPROST	0.004%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	203767	MICRO LABS
TRAVOPROST	TRAVOPROST	0.004%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	205050	MYLAN
TRAVOPROST	TRAVOPROST	0.004%	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	217228	SOMERSET THERAPS LLC