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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 Therap and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. 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-three suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the fentanyl profile page.

Summary for NDA: 202788

Tradename:
SUBSYS
Applicant:
Insys Therap
Ingredient:
fentanyl
Patents:5
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Pharmacology for NDA: 202788

Mechanism of ActionFull Opioid Agonists

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY;SUBLINGUALStrength0.1MG
Approval Date:Jan 4, 2012TE:RLD:No
Patent:8,486,972Patent Expiration:Apr 27, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:8,835,459Patent Expiration:Jan 25, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:9,241,935Patent Expiration:Jan 25, 2027Product Flag?YSubstance Flag?Delist Request?


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