Product Details for ANDA 078383
PIOGLITAZONE HYDROCHLORIDE (PIOGLITAZONE HYDROCHLORIDE)
EQ 15MG BASE
Marketing Status: Discontinued
EQ 30MG BASE
Marketing Status: Discontinued
EQ 45MG BASE
Marketing Status: Discontinued
EQ 15MG BASE
Marketing Status: Discontinued
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:
Application Number: A078383
Product Number: 001
Approval Date: Mar 12, 2013
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
PIOGLITAZONE HYDROCHLORIDE (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:
Application Number: A078383
Product Number: 001
Approval Date: Mar 12, 2013
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 30MG BASE
Marketing Status: Discontinued
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:
Application Number: A078383
Product Number: 002
Approval Date: Mar 12, 2013
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
PIOGLITAZONE HYDROCHLORIDE (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:
Application Number: A078383
Product Number: 002
Approval Date: Mar 12, 2013
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
EQ 45MG BASE
Marketing Status: Discontinued
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:
Application Number: A078383
Product Number: 003
Approval Date: Mar 12, 2013
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: PIOGLITAZONE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: EQ 45MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A078383
Product Number: 003
Approval Date: Mar 12, 2013
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status: Discontinued
Patent and Exclusivity Information