Details for New Drug Application (NDA): 020973

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NDA 020973 describes ACIPHEX, which is a drug marketed by Waylis Therap and Aytu and is included in two NDAs. It is available from two suppliers. Additional details are available on the ACIPHEX profile page.

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

Summary for 020973

Tradename:	ACIPHEX
Applicant:	Waylis Therap
Ingredient:	rabeprazole sodium
Patents:	0

Pharmacology for NDA: 020973

Mechanism of Action	Proton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for 020973

Anti-Ulcer Agents
Proton Pump Inhibitors

Suppliers and Packaging for NDA: 020973

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973	NDA	Woodward Pharma Services LLC	69784-243	69784-243-30	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69784-243-30)
ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973	NDA	Waylis Therapeutics LLC	80725-243	80725-243-30	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80725-243-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	May 29, 2002	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	20MG
Approval Date:	Aug 19, 1999	TE:	AB	RLD:	Yes

Expired US Patents for NDA 020973

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002	⤷ Subscribe	⤷ Subscribe
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999	⤷ Subscribe	⤷ Subscribe
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-002	Aug 19, 1999	⤷ Subscribe	⤷ Subscribe
Waylis Therap	ACIPHEX	rabeprazole sodium	TABLET, DELAYED RELEASE;ORAL	020973-001	May 29, 2002	⤷ Subscribe	⤷ Subscribe
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