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… 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 | Omnicef (cefdinir) capsules, Abbott Laboratories, Labeling Revision | Omnicef (cefdinir) powder for oral suspension, Abbott Laboratories, Labeling Revision | Cefdinir Capsules, Lupin Ltd., Approval | Cefdinir Oral Suspension, Lupin Ltd., Approval | Cefdinir Capsules, Sandoz Inc., Approval | Cefdinir Oral Suspension, Sandoz Inc., Approval | Cefdinir Oral Suspension, Teva Pharma, Approval | Cefdinir Capsules, Teva Pharma, Approval | OMNICEF (cefdinir) Capsules, Abbott Labs, Labeling Revision | OMNICEF Oral Suspension, Abbott Labs, Labeling Revision | Cefdinir Capsules, Orchid Healthcare, Approval | Cefdinir Oral Suspension, Orchid Healthcare, Approval | OMNICEF (cefdinir) Capsules, Abbott Labs, Labeling Revision | OMNICEF (cefdinir) Oral Suspension, Abbott Labs, Labeling Revision | Cefdinir Oral Suspension, Aurobindo Pharma, Approval | Cefdinir Capsules, Aurobindo Pharma, Approval | Omnicef (cefdinir) Capsules, Abbott Laboratories, Labeling Revision | Omnicef (cefdinir) Oral Suspension, Abbott Laboratories, 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 © 2009 Betterchem.com