Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018675
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAVIST CLEMASTINE FUMARATE EQ 0.5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No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
06/28/1985 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
02/11/2002 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

06/14/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

08/30/1994 SUPPL-6 Labeling

Label is not available on this site.

07/21/1994 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/1987 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1986 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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