13551-101 : Karbinal 4 mg/5ml Oral Suspension, Extended Release

Labeler: Fsc Laboratories, Inc
Product Type: Human Prescription Drug
Drug Name:  Karbinal ER
Dosage Form: Oral Suspension, Extended Release
Application #: NDA022556
Rev. Date: 

NDC Package Codes:

  • 13551-101-01: 2 BOTTLE, PLASTIC IN 1 CARTON (13551‑101‑01) > 30 ML IN 1 BOTTLE, PLASTIC
  • 13551-101-05: 480 ML IN 1 BOTTLE, PLASTIC (13551‑101‑05)

Active Ingredients:

  • Carbinoxamine Maleate

Dosage Strength:

  • 4 mg/5mL

Pharmaceutical Classes:

  • Histamine H1 Receptor Antagonists [MoA]
  • Histamine-1 Receptor Antagonist [EPC]

Related Products:

Based on records with the same trade name.
  • 23594-101 Karbinal 4 mg/5ml Oral Suspension, Extended Release by Zylera Pharmaceuticals, LLC


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