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Details for New Drug Application (NDA): 204736

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

The generic ingredient in ACIPHEX SPRINKLE is rabeprazole sodium. There are twenty-nine 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 NDA: 204736

Tradename:
ACIPHEX SPRINKLE
Applicant:
Fsc Therap
Ingredient:
rabeprazole sodium
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204736

Mechanism of ActionProton Pump Inhibitors

Suppliers and Packaging for NDA: 204736

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACIPHEX SPRINKLE
rabeprazole sodium
CAPSULE, DELAYED RELEASE;ORAL 204736 NDA FSC Laboratories, Inc. 13551-205 13551-205-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (13551-205-01)
ACIPHEX SPRINKLE
rabeprazole sodium
CAPSULE, DELAYED RELEASE;ORAL 204736 NDA FSC Laboratories, Inc. 13551-210 13551-210-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (13551-210-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength5MG
Approval Date:Mar 26, 2013TE:RLD:No
Regulatory Exclusivity Expiration:Mar 26, 2016
Regulatory Exclusivity Use:NEW DOSAGE FORM
Regulatory Exclusivity Expiration:Sep 26, 2016
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength10MG
Approval Date:Mar 26, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 26, 2016
Regulatory Exclusivity Use:NEW DOSAGE FORM

Expired Orange Book Patents for NDA: 204736

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fsc Therap
ACIPHEX SPRINKLE
rabeprazole sodium
CAPSULE, DELAYED RELEASE;ORAL204736-001Mar 26, 20135,045,552*PED► subscribe
Fsc Therap
ACIPHEX SPRINKLE
rabeprazole sodium
CAPSULE, DELAYED RELEASE;ORAL204736-002Mar 26, 20135,045,552*PED► subscribe
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