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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074326
Company: BAUSCH AND LOMB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOBUNOLOL HYDROCHLORIDE LEVOBUNOLOL HYDROCHLORIDE 0.5% 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
03/04/1994 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
06/22/2023 SUPPL-38 Labeling-Package Insert

Label is not available on this site.
06/22/2023 SUPPL-33 Labeling-Package Insert

Label is not available on this site.
12/19/2002 SUPPL-19 Labeling

Label is not available on this site.
11/27/2001 SUPPL-18 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
03/07/2001 SUPPL-17 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
10/05/2000 SUPPL-16 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
06/27/2000 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
05/15/2000 SUPPL-14 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
04/28/2000 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
05/18/2000 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
06/07/1999 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
03/22/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
10/08/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
11/19/1998 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.
01/28/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
03/11/1998 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
05/30/1996 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
11/22/1995 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
11/22/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.
05/12/1994 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

LEVOBUNOLOL HYDROCHLORIDE

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BETAGAN LEVOBUNOLOL HYDROCHLORIDE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription Yes AT 019219 ALLERGAN
LEVOBUNOLOL HYDROCHLORIDE LEVOBUNOLOL HYDROCHLORIDE 0.5% SOLUTION/DROPS;OPHTHALMIC Prescription No AT 074326 BAUSCH AND LOMB
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