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… BreathTek UBT Meretek Diagnostics NDA 20586/S4 UREA, C-13 For Solution; 75MG /POUCHE BREATHTEK UBT FOR H-PYLORI MERETEK UREA, C-14 Capsule; 1uCi PYTEST BALLARD MEDCL 020617 UREA, C-14 Capsule; 1uCi PYTEST KIT BALLARD MEDICAL HYDROCORTISONE ACETATE; UREA Cream; Topical 1%;10% CARMOL HC KENWOOD 089472 AT HYDROCORTISONE ACETATE; UREA Cream; Topical 1%;10% U-CORT Taro 012154 UREA Injection 40GM/VIAL UREAPHIL Abbott 020586 UREA, C-13 For Solution; 75MG /POUCHE BREATHTEK UBT FOR H-PYLORI MERETEK 020617 UREA, C-14 Capsule; 1uCi PYTEST BALLARD MEDCL 020617 UREA, C-14 Capsule; 1uCi PYTEST KIT BALLARD MEDCL   For the latest approval information, locate this drug using this index.