Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022024

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ACTOPLUS MET XR (METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE)
1GM;EQ 15MG BASE
Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: ACTOPLUS MET XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1GM;EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022024
Product Number: 001
Approval Date: May 12, 2009
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

ACTOPLUS MET XR (METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE)
1GM;EQ 30MG BASE
Marketing Status: Discontinued

Active Ingredient: METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: ACTOPLUS MET XR
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 1GM;EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022024
Product Number: 002
Approval Date: May 12, 2009
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Discontinued
Patent and Exclusivity Information