Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020925
Company: GLAXOSMITHKLINE CONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TAVIST-1 CLEMASTINE FUMARATE 1.34MG TABLET;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
08/21/1992 ORIG-1 Approval Type 8 - Partial Rx to OTC Switch UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/12/2002 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/22/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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