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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "019618."



Active Ingredient: MESALAMINE
Dosage Form;Route: ENEMA;RECTAL
Proprietary Name: ROWASA
Applicant: MEDA PHARMS
Strength: 4GM/60ML
Application Number: N019618
Product Number: 001
Approval Date: Dec 24, 1987
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: MESALAMINE
Dosage Form;Route: ENEMA;RECTAL
Proprietary Name: SFROWASA
Applicant: MEDA PHARMS
Strength: 4GM/60ML
Application Number: N019618
Product Number: 002
Approval Date: Jun 20, 2008
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through August 2014
Patent and Generic Drug Product Data Last Updated September 17, 2014

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