Composition
- Active ingredients
- MESALAMINE 500MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- MESALAMINE 800MG · Tablet, delayed releaseANDA203286-001 · Prescription
- MESALAMINE 400MG · Capsule, delayed releaseANDA207873-001 · Prescription
- MESALAMINE 375MG · Capsule, extended releaseANDA214242-001 · Prescription
- MESALAMINE 1.2GM · Tablet, delayed releaseANDA216334-001 · Prescription
- MESALAMINE 1GM · SuppositoryANDA208953-001 · Prescription
- MESALAMINE 800MG · Tablet, delayed releaseANDA215067-001 · Prescription
- MESALAMINE 375MG · Capsule, extended releaseANDA219864-001 · Prescription
- MESALAMINE 1GM · SuppositoryANDA207448-001 · Prescription
- MESALAMINE 1.2GM · Tablet, delayed releaseANDA217337-001 · Prescription
- MESALAMINE 375MG · Capsule, extended releaseANDA218410-001 · Prescription
- MESALAMINE 4GM/60ML · EnemaANDA076751-001 · Prescription
- MESALAMINE 4GM/60ML · EnemaANDA076841-001 · Discontinued
- MESALAMINE 1.2GM · Tablet, delayed release
At a glance
- Brand name
- Mesalamine
- Route
- Oral
- Dosage form
- Capsule, extended release
- Applicant
- Difgen Pharms
- Status
- Prescription
- FDA approval
- 10 Mar 2026
- Application
- ANDA219997-002