Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084476
Company: BAYER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DOMEBORO 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
04/30/1976 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
02/24/1994 SUPPL-10 Labeling

Label is not available on this site.

10/29/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/29/1985 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/19/1982 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

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