Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075386
Company: AKORN

Products on ANDA 075386

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 075386

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2000	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75386ltr.pdf

Therapeutic Equivalents for ANDA 075386

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	075386	AKORN
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 INC