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Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204736

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NDA 204736 describes ACIPHEX SPRINKLE, which is a drug marketed by Cerecor Inc 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 thirty drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the rabeprazole sodium profile page.
Summary for 204736
Tradename:ACIPHEX SPRINKLE
Applicant:Cerecor Inc
Ingredient:rabeprazole sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 204736
Mechanism of ActionProton Pump Inhibitors
Medical Subject Heading (MeSH) Categories for 204736
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 Zylera Pharmaceuticals, LLC 23594-205 23594-205-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (23594-205-01)
ACIPHEX SPRINKLE rabeprazole sodium CAPSULE, DELAYED RELEASE;ORAL 204736 NDA Zylera Pharmaceuticals, LLC 23594-210 23594-210-01 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (23594-210-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength5MG
Approval Date:Mar 26, 2013TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, DELAYED RELEASE;ORALStrength10MG
Approval Date:Mar 26, 2013TE:RLD:Yes

Expired US Patents for NDA 204736

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cerecor Inc ACIPHEX SPRINKLE rabeprazole sodium CAPSULE, DELAYED RELEASE;ORAL 204736-001 Mar 26, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Cerecor Inc ACIPHEX SPRINKLE rabeprazole sodium CAPSULE, DELAYED RELEASE;ORAL 204736-002 Mar 26, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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Queensland Health
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