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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078694
Company: ACELLA

Products on ANDA 078694

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078694

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/16/2009	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 078694

BETAXOLOL HYDROCHLORIDE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	078694	ACELLA
BETAXOLOL HYDROCHLORIDE	BETAXOLOL HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	No	AT	075630	MEDIMETRIKS PHARMS
BETOPTIC	BETAXOLOL HYDROCHLORIDE	EQ 0.5% BASE	SOLUTION/DROPS;OPHTHALMIC	Prescription	Yes	AT	019270	SANDOZ

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