20482-002 : Subsys .2 mg/1 Sublingual Spray

NDC:	20482-002
Labeler:	Insys Therapeutics, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Subsys
Dosage Form:	Sublingual Spray
Application #:	NDA202788
Rev. Date:	Mar 13, 2012
CSA Schedule:	CII (US) [1]

^[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

• 20482-002-10: 10 BLISTER PACK IN 1 CARTON (20482‑002‑10) > 1 BOTTLE, SPRAY IN 1 BLISTER PACK > 1 SPRAY IN 1 BOTTLE, SPRAY
• 20482-002-30: 30 BLISTER PACK IN 1 CARTON (20482‑002‑30) > 1 BOTTLE, SPRAY IN 1 BLISTER PACK > 1 SPRAY IN 1 BOTTLE, SPRAY

Active Ingredients:

• Fentanyl

Pharmaceutical Classes:

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.

• 20482-001 Subsys .1 mg/1 Sublingual Spray by Insys Therapeutics, Inc.
• 20482-004 Subsys .4 mg/1 Sublingual Spray by Insys Therapeutics, Inc.
• 20482-006 Subsys .6 mg/1 Sublingual Spray by Insys Therapeutics, Inc.
• 20482-008 Subsys .8 mg/1 Sublingual Spray by Insys Therapeutics, Inc.
• 20482-012 Subsys .6 mg/1 Sublingual Spray by Insys Therapeutics, Inc.
• 20482-016 Subsys .8 mg/1 Sublingual Spray by Insys Therapeutics, Inc.

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