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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 "022037."



Active Ingredient: GUANFACINE HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: INTUNIV
Applicant: SHIRE
Strength: EQ 1MG BASE
Application Number: N022037
Product Number: 001
Approval Date: Sep 2, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: GUANFACINE HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: INTUNIV
Applicant: SHIRE
Strength: EQ 2MG BASE
Application Number: N022037
Product Number: 002
Approval Date: Sep 2, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: GUANFACINE HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: INTUNIV
Applicant: SHIRE
Strength: EQ 3MG BASE
Application Number: N022037
Product Number: 003
Approval Date: Sep 2, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: GUANFACINE HYDROCHLORIDE
Dosage Form;Route: TABLET, EXTENDED RELEASE;ORAL
Proprietary Name: INTUNIV
Applicant: SHIRE
Strength: EQ 4MG BASE
Application Number: N022037
Product Number: 004
Approval Date: Sep 2, 2009
Reference Listed Drug Yes
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 November 2014
Patent and Generic Drug Product Data Last Updated December 19, 2014

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