FDA Approval Activities for this Drug…

Beconase (beclomethasone dopropionate) Nasal Aerosol, GlaxoSmithKline NDA 18-584/S-026 12/16/02 1/29/03 Beconase AQ (beclomethasone dopropionate) Nasal Spray, GlaxoSmithKline NDA 19-389/S-025 12/16/02 1/29/03 Beconase AQ (beclomethasone dopropionate) Nasal Spray, GlaxoSmithKline NDA 19-389/S-021 Qvar (beclomethasone dipropionate HFA) Inhalation Aerosol, 3M NDA 20-911/S8 8/1/03 8/15/03 Qvar Inhalation Aerosol (beclomethasone dipropionate HFA), 3M NDA 20-911/S5 5/9/02 5/21/02 Qvar Inhalation Aerosol (beclomethasone dipropionate HFA 40 mcg and 80 mcg), 3M NDA 20-911 9/15/00 QVar Indication: for the maintenance treatment of asthma as prophylactic therapy. QVar is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVar may reduce or eliminate the need for the systemic corticosteroids. Vanceril (Beclomethasone Dipropionate) Inhalation Aerosol Schering NDA 17-573/S040 BECLOMETHASONE DIPROPIONATE Aerosol, Metered; Inhalation 0.04MG/INH QVAR 40 3M 020911 BECLOMETHASONE DIPROPIONATE Aerosol, Metered; Inhalation 0.08MG/INH QVAR 80 3M 017573 BN BECLOMETHASONE DIPROPIONATE Aerosol, Metered; Inhalation 0.042MG/INH VANCERIL SCHERING 020486 BECLOMETHASONE DIPROPIONATE Aerosol, Metered; Inhalation 0.084MG/INH VANCERIL DOUBLE STRENGTH SCHERING 019389 BN BECLOMETHASONE DIPROPIONATE MONOHYDRATE Spray, Metered; Nasal 0.042MG DIPROP/SPRAY BECONASE AQ GLAXOSMITHKLINE 019589 BN BECLOMETHASONE DIPROPIONATE MONOHYDRATE Spray, Metered; Nasal 0.042MG DIPROP/SPRAY VANCENASE AQ SCHERING

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