Details for New Drug Application (NDA): 022106

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NDA 022106 describes DORIBAX, which is a drug marketed by Shionogi Inc and is included in one NDA. Additional details are available on the DORIBAX profile page.

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INJECTABLE;INTRAVENOUS			Strength	500MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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INJECTABLE;INTRAVENOUS			Strength	250MG/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010	5,317,016	⤷ Try for Free
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007	8,247,402	⤷ Try for Free
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-002	Oct 5, 2010	8,247,402	⤷ Try for Free
Shionogi Inc	DORIBAX	doripenem	INJECTABLE;INTRAVENOUS	022106-001	Oct 12, 2007	5,317,016	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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