|
Drug Name
|
Active Ingredient
|
Dosage Form/Route
|
Sponsor
|
Submission Type
|
|
Asmanex Hfa
|
mometasone furoate
|
Aerosol, Metered;Inhalation
|
Merck Sharp Dohme
|
Manufacturing Change or Addition
|
|
Bio-Tropin
|
somatropin recombinant
|
Injectable;Injection
|
Ferring
|
Manufacturing Change or Addition
|
|
Climara
|
estradiol
|
Film, Extended Release;Transdermal
|
Bayer Hlthcare
|
Manufacturing Change or Addition
|
|
Commit
|
nicotine polacrilex
|
Troche/Lozenge;Oral
|
Glaxosmithkline Cons
|
Labeling Revision
|
|
Dulera
|
formoterol fumarate; mometasone furoate
|
Aerosol, Metered;Inhalation
|
Merck Sharp Dohme
|
Manufacturing Change or Addition
|
|
Nicoderm Cq
|
nicotine
|
Film, Extended Release;Transdermal
|
Sanofi Aventis Us
|
Labeling Revision
|
|
Solu-Medrol
|
methylprednisolone sodium succinate
|
Injectable;Injection
|
Pharmacia and Upjohn
|
Manufacturing Change or Addition
|
|
Varithena
|
polidocanol
|
Solution;Intravenous
|
Provensis
|
Manufacturing Change or Addition
|
|
Zomacton
|
somatropin recombinant
|
Injectable;Injection
|
Ferring
|
Manufacturing Change or Addition
|