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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202667
Company: THEA PHARMA

Summary Review

Products on NDA 202667

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COSOPT PF	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT2	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202667

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/01/2012	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202667s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202667s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202667_cosoptpf_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202667Orig1s000SumR.pdf

Labels for NDA 202667

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/01/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202667s000lbl.pdf

Therapeutic Equivalents for NDA 202667

COSOPT PF

SOLUTION/DROPS;OPHTHALMIC; EQ 2% BASE;EQ 0.5% BASE
TE Code = AT2

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COSOPT PF	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT2	202667	THEA PHARMA
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	207630	EUGIA PHARMA
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	217260	INGENUS PHARMS LLC
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT2	215936	MICRO LABS

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