Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207806

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PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE HYDROCHLORIDE)
EQ 15MG BASE
Marketing Status: Prescription

Active Ingredient: PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: PIOGLITAZONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 15MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207806
Product Number: 001
Approval Date: Apr 17, 2018
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE HYDROCHLORIDE)
EQ 30MG BASE
Marketing Status: Prescription

Active Ingredient: PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: PIOGLITAZONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 30MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207806
Product Number: 002
Approval Date: Apr 17, 2018
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information

PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE HYDROCHLORIDE)
EQ 45MG BASE
Marketing Status: Prescription

Active Ingredient: PIOGLITAZONE HYDROCHLORIDE
Proprietary Name: PIOGLITAZONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 45MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207806
Product Number: 003
Approval Date: Apr 17, 2018
Applicant Holder Full Name: PRINSTON PHARMACEUTICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information