Details for New Drug Application (NDA): 204736

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NDA 204736 describes ACIPHEX SPRINKLE, which is a drug marketed by Aytu and is included in one NDA. Additional details are available on the ACIPHEX SPRINKLE profile page.

The generic ingredient in ACIPHEX SPRINKLE is rabeprazole sodium. There are thirty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.

Summary for 204736

Tradename:	ACIPHEX SPRINKLE
Applicant:	Aytu
Ingredient:	rabeprazole sodium
Patents:	0

Medical Subject Heading (MeSH) Categories for 204736

Anti-Ulcer Agents
Proton Pump Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	5MG
Approval Date:	Mar 26, 2013	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, DELAYED RELEASE;ORAL			Strength	10MG
Approval Date:	Mar 26, 2013	TE:		RLD:	Yes

Expired US Patents for NDA 204736

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-001	Mar 26, 2013	⤷ Sign Up	⤷ Sign Up
Aytu	ACIPHEX SPRINKLE	rabeprazole sodium	CAPSULE, DELAYED RELEASE;ORAL	204736-002	Mar 26, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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