Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018746
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VASOCON-A ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE 0.5%;0.05% 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
04/30/1990 ORIG-1 Approval Type 6 - New Indication (no longer used) 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
01/02/2001 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/06/1997 SUPPL-9 Labeling

Label is not available on this site.

03/13/1995 SUPPL-8 Labeling

Label is not available on this site.

08/03/1995 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/11/1994 SUPPL-6 Efficacy-Rx To OTC Switch

Label is not available on this site.

08/22/1995 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1990 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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