Details for New Drug Application (NDA): 022173

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NDA 022173 describes ZYPREXA RELPREVV, which is a drug marketed by Cheplapharm and is included in one NDA. It is available from one supplier. Additional details are available on the ZYPREXA RELPREVV profile page.

The generic ingredient in ZYPREXA RELPREVV is olanzapine pamoate. There are thirty-three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olanzapine pamoate profile page.

Summary for 022173

Tradename:	ZYPREXA RELPREVV
Applicant:	Cheplapharm
Ingredient:	olanzapine pamoate
Patents:	0

Suppliers and Packaging for NDA: 022173

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173	NDA	H2-Pharma LLC	61269-660	61269-660-20	1 KIT in 1 CARTON (61269-660-20) * 1.4 mL in 1 VIAL (61269-663-01) * 3 mL in 1 VIAL (61269-670-01)
ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173	NDA	H2-Pharma LLC	61269-661	61269-661-20	1 KIT in 1 CARTON (61269-661-20) * 2 mL in 1 VIAL (61269-664-01) * 3 mL in 1 VIAL (61269-670-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	EQ 210MG BASE/VIAL
Approval Date:	Dec 11, 2009	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	EQ 300MG BASE/VIAL
Approval Date:	Dec 11, 2009	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	EQ 405MG BASE/VIAL
Approval Date:	Dec 11, 2009	TE:		RLD:	Yes

Expired US Patents for NDA 022173

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-003	Dec 11, 2009	5,229,382*PED	⤷ Subscribe
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-001	Dec 11, 2009	5,229,382*PED	⤷ Subscribe
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-003	Dec 11, 2009	6,169,084	⤷ Subscribe
Cheplapharm	ZYPREXA RELPREVV	olanzapine pamoate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022173-002	Dec 11, 2009	6,169,084	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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