Details for New Drug Application (NDA): 200823
✉ Email this page to a colleague
NDA 200823 describes PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Chartwell Rx, Macleods Pharms Ltd, Pharmobedient, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in six NDAs. It is available from five suppliers. Additional details are available on the PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE profile page.
The generic ingredient in PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE is metformin hydrochloride; pioglitazone hydrochloride. There are forty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.
The generic ingredient in PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE is metformin hydrochloride; pioglitazone hydrochloride. There are forty-nine drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; pioglitazone hydrochloride profile page.
Summary for 200823
| Tradename: | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | metformin hydrochloride; pioglitazone hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 200823
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 200823 | ANDA | Rising Pharma Holdings, Inc. | 57237-217 | 57237-217-60 | 60 TABLET, FILM COATED in 1 BOTTLE (57237-217-60) |
| PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 200823 | ANDA | Rising Pharma Holdings, Inc. | 57237-217 | 57237-217-81 | 180 TABLET, FILM COATED in 1 BOTTLE (57237-217-81) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG;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 | 850MG;EQ 15MG BASE | ||||
| Approval Date: | Feb 13, 2013 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
