Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019618

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ROWASA (MESALAMINE)
4GM/60ML
Marketing Status: Prescription

Active Ingredient: MESALAMINE
Proprietary Name: ROWASA
Dosage Form; Route of Administration: ENEMA; RECTAL
Strength: 4GM/60ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N019618
Product Number: 001
Approval Date: Dec 24, 1987
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
Patent and Exclusivity Information

SFROWASA (MESALAMINE)
4GM/60ML
Marketing Status: Prescription

Active Ingredient: MESALAMINE
Proprietary Name: SFROWASA
Dosage Form; Route of Administration: ENEMA; RECTAL
Strength: 4GM/60ML
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N019618
Product Number: 002
Approval Date: Jun 20, 2008
Applicant Holder Full Name: MYLAN SPECIALTY LP
Marketing Status:  Prescription
Patent and Exclusivity Information