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Generated: November 17, 2018

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Details for New Drug Application (NDA): 202788

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NDA 202788 describes SUBSYS, which is a drug marketed by Insys Dev Co Inc and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug and two Paragraph IV challenges. Additional details are available on the SUBSYS profile page.

The generic ingredient in SUBSYS is fentanyl. There are thirty-one drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fentanyl profile page.
Summary for 202788
Tradename:SUBSYS
Applicant:Insys Dev Co Inc
Ingredient:fentanyl
Patents:9
Formulation / Manufacturing:see details
Pharmacology for NDA: 202788
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 202788
Suppliers and Packaging for NDA: 202788
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SUBSYS fentanyl SPRAY;SUBLINGUAL 202788 NDA Insys Therapeutics, Inc. 20482-001 20482-001-10 10 BLISTER PACK in 1 CARTON (20482-001-10) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY
SUBSYS fentanyl SPRAY;SUBLINGUAL 202788 NDA Insys Therapeutics, Inc. 20482-001 20482-001-30 30 BLISTER PACK in 1 CARTON (20482-001-30) > 1 BOTTLE, SPRAY in 1 BLISTER PACK > 1 SPRAY in 1 BOTTLE, SPRAY

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;SUBLINGUALStrength0.1MG
Approval Date:Jan 4, 2012TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 25, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Apr 27, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:Apr 27, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PAIN

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