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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 "011011."



Active Ingredient: METHOCARBAMOL
Dosage Form;Route: TABLET;ORAL
Proprietary Name: ROBAXIN
Applicant: AUXILIUM PHARMS LLC
Strength: 500MG
Application Number: N011011
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AA
Patent and Exclusivity Info for this product: View

Active Ingredient: METHOCARBAMOL
Dosage Form;Route: TABLET;ORAL
Proprietary Name: ROBAXIN-750
Applicant: AUXILIUM PHARMS LLC
Strength: 750MG
Application Number: N011011
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
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 September 2014
Patent and Generic Drug Product Data Last Updated October 22, 2014

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