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  • Pioglitazone PIOGLITAZONE HYDROCHLORIDE 15 mg/1 Zydus Lifesciences Limited
FDA Drug information

Pioglitazone

Read time: 1 mins
Marketing start date: 18 Nov 2024

Summary of product characteristics


Effective Time

20230927

Version

8

Spl Product Data Elements

pioglitazone pioglitazone PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE CARBOXYMETHYLCELLULOSE CALCIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED off-white to cream white ROUND 306 pioglitazone pioglitazone PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE CARBOXYMETHYLCELLULOSE CALCIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED off-white to cream white ROUND 307 pioglitazone pioglitazone PIOGLITAZONE HYDROCHLORIDE PIOGLITAZONE CARBOXYMETHYLCELLULOSE CALCIUM LACTOSE MONOHYDRATE MAGNESIUM STEARATE HYDROXYPROPYL CELLULOSE, UNSPECIFIED off-white to cream white ROUND 308

Application Number

ANDA202456

Brand Name

Pioglitazone

Generic Name

pioglitazone

Product Ndc

70771-1021

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1021-3 in bottle of 30 tablets Pioglitazone Tablets USP, 15 mg R x only 30 tablets NDC 70771-1022-3 in bottle of 30 tablets Pioglitazone Tablets USP, 30 mg R x only 30 tablets NDC 70771-1023-3 in bottle of 30 tablets Pioglitazone Tablets USP, 45 mg R x only 30 tablets Pioglitazone Tablets USP, 15 mg Pioglitazone Tablets USP, 30 mg Pioglitazone Tablets USP, 45 mg

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Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.