Details for New Drug Application (NDA): 022106
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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 |
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| INJECTABLE;INTRAVENOUS | Strength | 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| INJECTABLE;INTRAVENOUS | Strength | 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | 022106-002 | Oct 5, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Shionogi Inc | DORIBAX | doripenem | INJECTABLE;INTRAVENOUS | 022106-001 | Oct 12, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Shionogi Inc | DORIBAX | doripenem | INJECTABLE;INTRAVENOUS | 022106-001 | Oct 12, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Shionogi Inc | DORIBAX | doripenem | INJECTABLE;INTRAVENOUS | 022106-002 | Oct 5, 2010 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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