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… Omnicef (cefdinir) Capsules, Abbott NDA 50-739/S-006 7/24/02 8/6/02 Omnicef (cefdinir) Capsules, Parke-Davis NDA 50-739/S-002 11/24/99 12/30/99 12/30/99 Omnicef (cefdinir) Powder Suspension Parke-Davis NDA 50-749/SE2-002 7/14/99 7/29/99 7/29/99 Omnicef Indication: 5-day dosing regimen (7 mg/kg BID) for the treatment of AOM Omnicef (cefdinir) for Oral Suspension, Abbott Laboratories, Control Supplement Omnicef (cefdinir) capsules, Abbott Laboratories, Labeling Revision   For the latest approval information, locate this drug using this index.