Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074779
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AKBETA LEVOBUNOLOL HYDROCHLORIDE 0.25% 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
10/29/1996 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/07/1999 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

AKBETA

SOLUTION/DROPS;OPHTHALMIC; 0.25%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AKBETA LEVOBUNOLOL HYDROCHLORIDE 0.25% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074779 AKORN
BETAGAN LEVOBUNOLOL HYDROCHLORIDE 0.25% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 019814 ALLERGAN

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