Drugs@FDA: FDA-Approved Drugs

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

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

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

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 075386 AKORN
BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 075630 MEDIMETRIKS PHARMS
BETAXOLOL HYDROCHLORIDE BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription No AT 078694 WOCKHARDT
BETOPTIC BETAXOLOL HYDROCHLORIDE EQ 0.5% BASE SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 019270 SANDOZ INC

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