Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018471
Company: BAYER HEALTHCARE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OCUCLEAR OXYMETAZOLINE HYDROCHLORIDE 0.025% 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
05/30/1986 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/06/2001 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1997 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/13/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/16/1990 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1989 SUPPL-11 Labeling

Label is not available on this site.

04/06/1989 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/09/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/30/1989 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

01/15/1988 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

08/04/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/12/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/03/1987 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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