Search results from the "OB_Rx" table for query on "021589."



Active Ingredient: BACLOFEN
Dosage Form;Route: TABLET, ORALLY DISINTEGRATING; ORAL
Proprietary Name: KEMSTRO
Applicant: SCHWARZ PHARMA
Strength: 10MG
Application Number: 021589
Product Number: 001
Approval Date: Oct 30, 2003
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: BACLOFEN
Dosage Form;Route: TABLET, ORALLY DISINTEGRATING; ORAL
Proprietary Name: KEMSTRO
Applicant: SCHWARZ PHARMA
Strength: 20MG
Application Number: 021589
Product Number: 002
Approval Date: Oct 30, 2003
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
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 October, 2009
    Patent and Generic Drug Product Data Last Updated: November 20, 2009