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Generated: November 18, 2018

DrugPatentWatch Database Preview

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 022408
Tradename:NATROBA
Applicant:Parapro Llc
Ingredient:spinosad
Patents:3
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022408
Generic Entry Date for 022408*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;TOPICALStrength0.9%
Approval Date:Jan 18, 2011TE:RLD:Yes
Patent:➤ Sign UpPatent 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.
Patent:➤ Sign UpPatent Expiration:Jun 22, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS FOUR (4) YEARS OF AGE AND OLDER
Patent:➤ Sign UpPatent Expiration:Jul 2, 2021Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS FOUR (4) YEARS OF AGE AND OLDER

Expired US Patents for NDA 022408

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Parapro Llc NATROBA spinosad SUSPENSION;TOPICAL 022408-001 Jan 18, 2011 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Cipla

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