57881-338 : Abstral 0.8 mg Sublingual Tablet

NDC:	57881-338
Labeler:	Galena Biopharma, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Abstral
Dosage Form:	Sublingual Tablet
Application #:	NDA022510
Rev. Date:	Aug 8, 2013
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.

Appearance:

Markings:	8
Shapes:	Capsule
Colors:	Blue
Size (mm):	10
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 57881-338-32: 8 BLISTER PACK IN 1 CARTON (57881‑338‑32) > 4 TABLET IN 1 BLISTER PACK (57881‑338‑04)

Active Ingredients:

• Fentanyl Citrate

Inactive Ingredients:

• Croscarmellose Sodium
• Magnesium Stearate
• Mannitol
• Cellulose, Microcrystalline

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

• 57881-331 Abstral 0.1 mg Sublingual Tablet by Galena Biopharma, Inc.
• 57881-332 Abstral 0.2 mg Sublingual Tablet by Galena Biopharma, Inc.
• 57881-333 Abstral 0.3 mg Sublingual Tablet by Galena Biopharma, Inc.
• 57881-334 Abstral 0.4 mg Sublingual Tablet by Galena Biopharma, Inc.
• 57881-336 Abstral 0.6 mg Sublingual Tablet by Galena Biopharma, Inc.
• 42747-221 Abstral 0.1 mg Sublingual Tablet by Prostrakan, Inc.
• 42747-222 Abstral 0.2 mg Sublingual Tablet by Prostrakan, Inc.
• 42747-223 Abstral 0.3 mg Sublingual Tablet by Prostrakan, Inc.
• 42747-224 Abstral 0.4 mg Sublingual Tablet by Prostrakan, Inc.
• 42747-226 Abstral 0.6 mg Sublingual Tablet by Prostrakan, Inc.
• 42747-228 Abstral 0.8 mg Sublingual Tablet by Prostrakan, Inc.

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