10094-205 : Sympazan 5 mg Oral Film

Labeler: Aquestive Therapeutics
Product Type: Human Prescription Drug
Drug Name:  Sympazan
Dosage Form: Oral Film
Application #: NDA210833
Rev. Date: 
CSA Schedule: CIV (US) [1]

[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 10094-205-60: 60 POUCH IN 1 PACKAGE (10094‑205‑60) > 1 FILM IN 1 POUCH (10094‑205‑01)

Active Ingredients:

  • Clobazam

Dosage Strength:

  • 5 mg

Pharmaceutical Classes:

  • Benzodiazepine [EPC]
  • Benzodiazepines [CS]
  • Cytochrome P450 2D6 Inhibitors [MoA]
  • Cytochrome P450 3A4 Inducers [MoA]

Related Products:

Based on records with the same trade name.
  • 10094-210 Sympazan 10 mg Oral Film by Aquestive Therapeutics
  • 10094-220 Sympazan 20 mg Oral Film by Aquestive Therapeutics


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