Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.