Generated: September 26, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 202429
, which is a drug marketed by Hoffmann La Roche and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the ZELBORAF profile page.
The generic ingredient in ZELBORAF is vemurafenib. One supplier is listed for this compound. Additional details are available on the vemurafenib profile page.
Summary for NDA: 202429
|Formulation / Manufacturing:||see details|
Pharmacology for NDA: 202429
Suppliers and Packaging for NDA: 202429
||National Drug Code
||1 BOTTLE, PLASTIC in 1 CARTON (50242-090-01) > 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
||1 BOTTLE, PLASTIC in 1 CARTON (50242-090-02) > 112 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
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Summary for product number 001
|Approval Date:||Aug 17, 2011||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Aug 31, 2019
|Regulatory Exclusivity Use:|
|Regulatory Exclusivity Expiration:||Aug 17, 2016
|Regulatory Exclusivity Use:||NEW CHEMICAL ENTITY|
|Regulatory Exclusivity Expiration:||Aug 17, 2018
|Regulatory Exclusivity Use:||ORPHAN DRUG EXCLUSIVITY|
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