Details for New Drug Application (NDA): 022106
✉ Email this page to a colleague
The generic ingredient in DORIBAX is doripenem. There are five drug master file entries for this compound. Additional details are available on the doripenem profile page.
Summary for 022106
Tradename: | DORIBAX |
Applicant: | Shionogi Inc |
Ingredient: | doripenem |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 12, 2007 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Oct 5, 2010 | TE: | RLD: | Yes |
Expired US Patents for NDA 022106
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Shionogi Inc | DORIBAX | doripenem | INJECTABLE;INTRAVENOUS | 022106-001 | Oct 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Shionogi Inc | DORIBAX | doripenem | INJECTABLE;INTRAVENOUS | 022106-001 | Oct 12, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Shionogi Inc | DORIBAX | doripenem | INJECTABLE;INTRAVENOUS | 022106-002 | Oct 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Shionogi Inc | DORIBAX | doripenem | INJECTABLE;INTRAVENOUS | 022106-002 | Oct 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription