Details for New Drug Application (NDA): 078670
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NDA 078670 describes PIOGLITAZONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Corepharma, Macleods Pharms Ltd, Pharmobedient, Prinston Inc, Puracap Pharm Llc, Sandoz, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Pharms Usa Inc, and is included in twenty-two NDAs. It is available from twenty suppliers. Additional details are available on the PIOGLITAZONE HYDROCHLORIDE profile page.
The generic ingredient in PIOGLITAZONE HYDROCHLORIDE is metformin hydrochloride; pioglitazone hydrochloride. There are forty-nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.
The generic ingredient in PIOGLITAZONE HYDROCHLORIDE is metformin hydrochloride; pioglitazone hydrochloride. There are forty-nine drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.
Summary for 078670
| Tradename: | PIOGLITAZONE HYDROCHLORIDE |
| Applicant: | Sandoz |
| Ingredient: | pioglitazone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 078670
| Mechanism of Action | Peroxisome Proliferator-activated Receptor Activity |
Suppliers and Packaging for NDA: 078670
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 078670 | ANDA | Bryant Ranch Prepack | 71335-1659 | 71335-1659-1 | 30 TABLET in 1 BOTTLE (71335-1659-1) |
| PIOGLITAZONE HYDROCHLORIDE | pioglitazone hydrochloride | TABLET;ORAL | 078670 | ANDA | Bryant Ranch Prepack | 71335-1659 | 71335-1659-2 | 90 TABLET in 1 BOTTLE (71335-1659-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 15MG BASE | ||||
| Approval Date: | Feb 13, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Feb 13, 2013 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 45MG BASE | ||||
| Approval Date: | Feb 13, 2013 | TE: | AB | RLD: | No | ||||
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