Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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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 "017534."



Active Ingredient: ASPIRIN; BUTALBITAL; CAFFEINE
Dosage Form;Route: CAPSULE; ORAL
Proprietary Name: FIORINAL
Applicant: WATSON LABS INC
Strength: 325MG;50MG;40MG
Application Number: N017534
Product Number: 005
Approval Date: Apr 16, 1986
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AA
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 May, 2013
    Patent and Generic Drug Product Data Last Updated: June 18, 2013
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