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Serving leading biopharmaceutical companies globally:

McKesson
Dow
US Army
Queensland Health
Julphar
Cipla
Moodys
Chubb
Daiichi Sankyo
McKinsey

Generated: October 17, 2017

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 NDA: 022408

Tradename:
1
Applicant:
1
Ingredient:
1
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:► SubscribePatent 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:► SubscribePatent 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

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, 2011► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Colorcon
QuintilesIMS
Medtronic
Cipla
McKinsey
Dow
Argus Health
Express Scripts
Cantor Fitzgerald
Accenture

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.

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