Product Details for NDA 021073
ACTOS (PIOGLITAZONE HYDROCHLORIDE)
EQ 15MG BASE
Marketing Status: Prescription
EQ 30MG BASE
Marketing Status: Prescription
EQ 45MG BASE
Marketing Status: Prescription
EQ 15MG BASE
Marketing Status: Prescription
Active Ingredient: PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: ACTOS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021073
Product Number: 001
Approval Date: Jul 15, 1999
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
ACTOS (PIOGLITAZONE HYDROCHLORIDE)
Proprietary Name: ACTOS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021073
Product Number: 001
Approval Date: Jul 15, 1999
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 30MG BASE
Marketing Status: Prescription
Active Ingredient: PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: ACTOS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021073
Product Number: 002
Approval Date: Jul 15, 1999
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
ACTOS (PIOGLITAZONE HYDROCHLORIDE)
Proprietary Name: ACTOS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021073
Product Number: 002
Approval Date: Jul 15, 1999
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 45MG BASE
Marketing Status: Prescription
Active Ingredient: PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: ACTOS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 45MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021073
Product Number: 003
Approval Date: Jul 15, 1999
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ACTOS
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 45MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021073
Product Number: 003
Approval Date: Jul 15, 1999
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status: Prescription
Patent and Exclusivity Information