APPLICATION
ANDA220313
TYPE
ANDA
ORIGINAL APPROVAL
2026-04-15
LATEST ACTION
2026-04-15
ROUTE
ORAL
DOSAGE FORM
LIQUID
MARKETING STATUS
None (Tentative Approval), Prescription
Products
GLYCEROL PHENYLBUTYRATENone (Tentative Approval)
GLYCEROL PHENYLBUTYRATE 450ML · LIQUID
GLYCEROL PHENYLBUTYRATEPrescription
GLYCEROL PHENYLBUTYRATE 1.1GM/ML · LIQUID · ORAL
GLYCEROL PHENYLBUTYRATENone (Tentative Approval)
GLYCEROL PHENYLBUTYRATE 1.1G/1ML · LIQUID
Approval history
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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