Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

Product Details for NDA 021842

ACTOPLUS MET (METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE)
500MG;EQ 15MG BASE
Marketing Status: Prescription

Active Ingredient: METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: ACTOPLUS MET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021842
Product Number: 001
Approval Date: Aug 29, 2005
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information

ACTOPLUS MET (METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE)
850MG;EQ 15MG BASE
Marketing Status: Prescription

Active Ingredient: METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: ACTOPLUS MET
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 850MG;EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021842
Product Number: 002
Approval Date: Aug 29, 2005
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information