Details for New Drug Application (NDA): 050749
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The generic ingredient in OMNICEF is cefdinir. There are twelve drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the cefdinir profile page.
Summary for 050749
Tradename: | OMNICEF |
Applicant: | Abbvie |
Ingredient: | cefdinir |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | 125MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 4, 1997 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | 250MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jul 29, 2004 | TE: | RLD: | Yes |
Expired US Patents for NDA 050749
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | OMNICEF | cefdinir | FOR SUSPENSION;ORAL | 050749-001 | Dec 4, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | OMNICEF | cefdinir | FOR SUSPENSION;ORAL | 050749-002 | Jul 29, 2004 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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