Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074851
Company: ALCON LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LEVOBUNOLOL HYDROCHLORIDE LEVOBUNOLOL HYDROCHLORIDE 0.25% SOLUTION/DROPS;OPHTHALMIC Discontinued None 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
10/28/1996 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
12/23/2002 SUPPL-13 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/01/2002 SUPPL-12 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/29/2002 SUPPL-11 Labeling

Label is not available on this site.

03/27/2002 SUPPL-9 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/02/2002 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/07/2000 SUPPL-7 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/28/2000 SUPPL-6 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/23/1999 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/21/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/07/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/04/1999 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/04/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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