Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Drug Recalls For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Relenza (zanamivir for inhalation), GlaxoSmithKline 21-036/S006 8/6/03 8/15/03 8/15/03 Relenza (zanamivir for inhalation), GlaxoSmithKline 21-036/S005 8/5/03 8/15/03 8/6/03 Relenza (zanamivir for inhalation), 5 mg, Glaxo Wellcome, 21-036/S004 4/27/01 05/08/03 Relenza (zanamivir for inhalation),5 mg, Patient Label Glaxo Wellcome, 21-036/S001 4/26/00 4/27/00 4/27/00 Relenza (zanamivir for inhalation) GlaxoWellcome NDA 21-036 7/26/99 12/30/99 7/27/99 12/27/99 Relenza Indication: For the treatment of uncomplicated acute illness due to influenza virus in adults and adolescents twelve years and older who have been symptomatic for no more than two days. | RELENZA (zanamivir) inhalation, GlaxoSmithKline, New or Modified Indication | RELENZA (zanamivir) Inhalation, GlaxoSmithKline, Labeling Revision | RELENZA (zanamivir) Inhalation, GlaxoSmithKline, Labeling Revision | RELENZA (zanamivir) Inhalation Powder, GlaxoSmithKline, Labeling Revision | Relenza (zanamivir) Inhalation Powder, GlaxoSmithKline, Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^   A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com