Details for New Drug Application (NDA): 050686
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The generic ingredient in CEDAX is ceftibuten dihydrate. Additional details are available on the ceftibuten dihydrate profile page.
Summary for 050686
Tradename: | CEDAX |
Applicant: | Si Pharms |
Ingredient: | ceftibuten dihydrate |
Patents: | 0 |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 20, 1995 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SUSPENSION;ORAL | Strength | EQ 180MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Dec 20, 1995 | TE: | RLD: | Yes |
Expired US Patents for NDA 050686
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Si Pharms | CEDAX | ceftibuten dihydrate | FOR SUSPENSION;ORAL | 050686-001 | Dec 20, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Si Pharms | CEDAX | ceftibuten dihydrate | FOR SUSPENSION;ORAL | 050686-002 | Dec 20, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Si Pharms | CEDAX | ceftibuten dihydrate | FOR SUSPENSION;ORAL | 050686-002 | Dec 20, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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