FDA
Glycerol Phenylbutyrate
The FDA lists this product in 9 strengths and forms.
Composition
- Active ingredients
- GLYCEROL PHENYLBUTYRATE 1.1G/ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- GLYCEROL PHENYLBUTYRATE 1.1GM/ML · LiquidANDA205742-001 · Prescription
- GLYCEROL PHENYLBUTYRATE 1.1GM/ML · LiquidANDA207694-001 · Prescription
- GLYCEROL PHENYLBUTYRATE 1.1GM/ML · LiquidANDA218738-001 · Prescription
- GLYCEROL PHENYLBUTYRATE 450ML · LiquidANDA220313-003 · Tentative approval
- GLYCEROL PHENYLBUTYRATE 1.1GM/ML · LiquidANDA220313-001 · Prescription
- GLYCEROL PHENYLBUTYRATE 1.1G/1ML · LiquidANDA220313-002 · Tentative approval
- GLYCEROL PHENYLBUTYRATE 1.1GM/ML · LiquidANDA219540-001 · Prescription
- GLYCEROL PHENYLBUTYRATE 1.1G/ML · LiquidThis page
- GLYCEROL PHENYLBUTYRATE 1.1GM/ML · LiquidANDA220568-001 · Prescription
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA215139.
At a glance
- Brand name
- Glycerol Phenylbutyrate
- Route
- Oral
- Dosage form
- Liquid
- Applicant
- Annora Pharma
- Status
- Tentative approval
- FDA approval
- 9 Aug 2022
- Application
- ANDA215139-001