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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203058
Company: EPIC PHARMA LLC

Products on ANDA 203058

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	AT1	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203058

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/22/2014	ORIG-1	Approval			Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203058Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203058Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2025	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
03/08/2023	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
03/08/2023	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 203058

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/22/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/203058Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 203058

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

SOLUTION/DROPS;OPHTHALMIC; EQ 2% BASE;EQ 0.5% BASE
TE Code = AT1

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
COSOPT	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT1	020869	THEA PHARMA
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	213099	ALEMBIC
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	090037	BAUSCH AND LOMB
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	203058	EPIC PHARMA LLC
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	207629	EUGIA PHARMA
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	205295	FDC LTD
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	215520	GLAND
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	204777	MICRO LABS
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	202054	REGCON HOLDINGS
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	078749	SANDOZ
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	090604	SANDOZ
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	207523	SOMERSET

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