Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212639
Company: ALEMBIC

Products on ANDA 212639

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 212639

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/09/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 212639

DORZOLAMIDE HYDROCHLORIDE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	212639	ALEMBIC
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	090143	BAUSCH AND LOMB
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	205294	FDC LTD
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	215660	GLAND PHARMA LTD
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	202053	INDOCO
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	204778	MICRO LABS
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078395	RUBICON
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078748	SANDOZ
DORZOLAMIDE HYDROCHLORIDE	DORZOLAMIDE HYDROCHLORIDE	EQ 2% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078981	SANDOZ