Generated: December 18, 2017
DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 022408
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, which is a drug marketed by Parapro Llc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the NATROBA profile page.
The generic ingredient in NATROBA is spinosad. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the spinosad profile page.
Summary for 022408
|Formulation / Manufacturing:||see details|
Pharmacology for NDA: 022408
Suppliers and Packaging for NDA: 022408
||National Drug Code
||Allegis Pharmaceuticals, LLC
||1 BOTTLE, PLASTIC in 1 CARTON (28595-570-04) > 120 mL in 1 BOTTLE, PLASTIC
||1 BOTTLE, PLASTIC in 1 CARTON (52246-929-04) > 120 mL in 1 BOTTLE, PLASTIC
|Complete Access Available with Subscription
Summary for product number 001
|Approval Date:||Jan 18, 2011||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Nov 30, 2017
|Regulatory Exclusivity Use:||INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY SECTION OF THE LABELING REGARDING A SAFETY STUDY IN PEDIATRIC SUBJECTS AGES 6 MONTHS TO 4 YEARS OF AGE WITH AN ACTIVE HEAD LICE INFESTATION|
|Patent:||► Subscribe||Patent Expiration:||Jul 25, 2023||Product Flag?||Y||Substance Flag?||Delist Request?|
|Patented Use:||NATROBA TOPICAL SUSPENSION IS A PEDICULICIDE INDICATED FOR THE TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS SIX (6) MONTHS OF AGE AND OLDER.|
|Patent:||► Subscribe||Patent Expiration:||Jun 22, 2019||Product Flag?||Y||Substance Flag?||Delist Request?|
|Patented Use:||TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS FOUR (4) YEARS OF AGE AND OLDER|
Expired Orange Book Patents for NDA: 022408
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