Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207630
Company: EUGIA PHARMA

Products on ANDA 207630

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT2	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207630

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2018	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207630Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/02/2023	SUPPL-1	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 207630

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

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