Details for New Drug Application (NDA): 022408

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NDA 022408 describes NATROBA, which is a drug marketed by Cipher and is included in one NDA. It is available from two suppliers. There is one patent 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:	Cipher
Ingredient:	spinosad
Patents:	1

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 AUTHORIZED GENERIC	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 AUTHORIZED GENERIC	ParaPRO LLC	52246-570	52246-570-04	1 BOTTLE, PLASTIC in 1 CARTON (52246-570-04) / 120 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;TOPICAL			Strength	0.9%
Approval Date:	Jan 18, 2011	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Apr 28, 2024
Regulatory Exclusivity Use:	FOR THE TOPICAL TREATMENT OF SCABIES INFESTATIONS IN ADULT AND PEDIATRIC PATIENTS 4 YEARS OF AGE AND OLDER
Patent:	⤷ Sign Up	Patent Expiration:	Nov 25, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	THE PRODUCT COMPOSITION (NATROBA) IS FOR THE TOPICAL TREATMENT OF HUMAN SCABIES MITE INFESTATIONS BY MELTING AND DELIVERING THE ACTIVE INGREDIENT, SPINOSAD, TO THE STRATUM CORNEUM WHERE SCABIES MITES LIVE AND BREED

Expired US Patents for NDA 022408

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