Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 080235
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VASOCON NAPHAZOLINE HYDROCHLORIDE 0.1% 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
06/07/1971 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
04/19/2001 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

06/10/1994 SUPPL-15 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

10/07/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/07/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/08/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/16/1991 SUPPL-8 Labeling

Label is not available on this site.

08/11/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/24/1983 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/28/1982 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/28/1982 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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