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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 213099
Company: ALEMBIC

Products on ANDA 213099

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 213099

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/04/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 213099

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 PHARMA LTD
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE	EQ 2% BASE;EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT1	202054	INDOCO
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	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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