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Details for New Drug Application (NDA): 022408

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NDA 022408 describes NATROBA, 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 NDA: 022408

Tradename:
NATROBA
Applicant:
Parapro Llc
Ingredient:
spinosad
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 022408

Suppliers and Packaging for NDA: 022408

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NATROBA
spinosad
SUSPENSION;TOPICAL 022408 NDA Allegis Pharmaceuticals, LLC 28595-570 28595-570-04 1 BOTTLE, PLASTIC in 1 CARTON (28595-570-04) > 120 mL in 1 BOTTLE, PLASTIC
NATROBA
spinosad
SUSPENSION;TOPICAL 022408 NDA ParaPRO LLC 52246-929 52246-929-04 1 BOTTLE, PLASTIC in 1 CARTON (52246-929-04) > 120 mL in 1 BOTTLE, PLASTIC

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;TOPICALStrength0.9%
Approval Date:Jan 18, 2011TE: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:6,063,771Patent Expiration:Jul 25, 2023Product Flag?YSubstance 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.
Regulatory Exclusivity Expiration:Jan 18, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

Expired Orange Book Patents for NDA: 022408

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Parapro Llc
NATROBA
spinosad
SUSPENSION;TOPICAL022408-001Jan 18, 20115,496,931► subscribe
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