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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022037

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INTUNIV (GUANFACINE HYDROCHLORIDE)
EQ 1MG BASE
Marketing Status: Prescription
Active Ingredient: GUANFACINE HYDROCHLORIDE
Proprietary Name: INTUNIV
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022037
Product Number: 001
Approval Date: Sep 2, 2009
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INTUNIV (GUANFACINE HYDROCHLORIDE)
EQ 2MG BASE
Marketing Status: Prescription
Active Ingredient: GUANFACINE HYDROCHLORIDE
Proprietary Name: INTUNIV
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022037
Product Number: 002
Approval Date: Sep 2, 2009
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INTUNIV (GUANFACINE HYDROCHLORIDE)
EQ 3MG BASE
Marketing Status: Prescription
Active Ingredient: GUANFACINE HYDROCHLORIDE
Proprietary Name: INTUNIV
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022037
Product Number: 003
Approval Date: Sep 2, 2009
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
INTUNIV (GUANFACINE HYDROCHLORIDE)
EQ 4MG BASE
Marketing Status: Prescription
Active Ingredient: GUANFACINE HYDROCHLORIDE
Proprietary Name: INTUNIV
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: EQ 4MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022037
Product Number: 004
Approval Date: Sep 2, 2009
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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