Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040063
Company: BAUSCH AND LOMB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE ACETIC ACID, GLACIAL; ALUMINUM ACETATE 2%;0.79% SOLUTION/DROPS;OTIC 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
02/25/1994 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
11/27/2001 SUPPL-11 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/26/2001 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/2001 SUPPL-9 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/07/2001 SUPPL-8 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/27/2000 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.

05/18/2000 SUPPL-5 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

06/07/1999 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

11/19/1998 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/22/1998 SUPPL-2 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/17/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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