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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: | 1 |
Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 022106
Generic Entry Date for 022106*:
Constraining patent/regulatory exclusivity:
Dosage:
INJECTABLE;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 500MG/VIAL | ||||
Approval Date: | Oct 12, 2007 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Mar 30, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INTRAVENOUS | Strength | 250MG/VIAL | ||||
Approval Date: | Oct 5, 2010 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Mar 30, 2021 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
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 | Start Trial | Start Trial |
Shionogi Inc | DORIBAX | doripenem | INJECTABLE;INTRAVENOUS | 022106-001 | Oct 12, 2007 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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