FDA Approval Activities for this Drug…

Clemastine Fumarate Syrup, 0.5 mg (base)/5 mL, Novex Pharma ANDA 75-703 Tavist Allergy/Sinus/Headache (0.335mg clemastine fumarate, 30mg pseudoephedrine hydrochloride, 500mg acetaminophen), OTC Novartis Consumer Health NDA 21-082 3/1/01 3/14/01 3/14/01 8/8/02 Tavist Indications: temporary relief of symptoms associated with hay fever allergic rhinitis, and the common cold. CLEMASTINE FUMARATE Syrup; 0.5MG BASE/5ML CLEMASTINE FUMARATE ALPHARMA 073095 CLEMASTINE FUMARATE Syrup; 0.5MG BASE/5ML CLEMASTINE FUMARATE Copley 074863 CLEMASTINE FUMARATE Syrup; 0.5MG BASE/5ML CLEMASTINE FUMARATE Morton Grove 075703 CLEMASTINE FUMARATE Syrup; 0.5MG BASE/5ML CLEMASTINE FUMARATE Novex 074884 CLEMASTINE FUMARATE Syrup; 0.5MG BASE/5ML CLEMASTINE FUMARATE SILARX 073399 CLEMASTINE FUMARATE Syrup; 0.5MG BASE/5ML CLEMASTINE FUMARATE Teva 073459 CLEMASTINE FUMARATE Tablet; 2.68MG CLEMASTINE FUMARATE Geneva 017661 CLEMASTINE FUMARATE Tablet; 2.68MG TAVIST NOVARTIS 073283 CLEMASTINE FUMARATE Tablet; 2.68MG CLEMASTINE FUMARATE Teva

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