Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022562

« Back to Dashboard
NDA 022562 describes CARBAGLU, which is a drug marketed by Orphan Europe and is included in one NDA. It is available from one supplier. Additional details are available on the CARBAGLU profile page.

The generic ingredient in CARBAGLU is carglumic acid. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the carglumic acid profile page.

Summary for NDA: 022562

Orphan Europe
carglumic acid

Pharmacology for NDA: 022562

Suppliers and Packaging for NDA: 022562

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
carglumic acid
TABLET;ORAL 022562 NDA Orphan Europe, SARL 52276-312 52276-312-05 5 TABLET in 1 BOTTLE (52276-312-05)
carglumic acid
TABLET;ORAL 022562 NDA Orphan Europe, SARL 52276-312 52276-312-60 60 TABLET in 1 BOTTLE (52276-312-60)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Mar 18, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 18, 2017
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY

Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.