Details for New Drug Application (NDA): 204802
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NDA 204802 describes PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Chartwell Rx, Macleods Pharms Ltd, Mylan, 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 204802
| Tradename: | PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | metformin hydrochloride; pioglitazone hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 204802
| Mechanism of Action | Peroxisome Proliferator-activated Receptor Activity |
Suppliers and Packaging for NDA: 204802
| 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 | 204802 | ANDA | Macleods Pharmaceuticals Limited | 33342-176 | 33342-176-09 | 60 TABLET in 1 BOTTLE (33342-176-09) |
| PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; pioglitazone hydrochloride | TABLET;ORAL | 204802 | ANDA | Macleods Pharmaceuticals Limited | 33342-176 | 33342-176-11 | 100 TABLET in 1 BOTTLE (33342-176-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG;EQ 15MG BASE | ||||
| Approval Date: | Nov 5, 2015 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 850MG;EQ 15MG BASE | ||||
| Approval Date: | Nov 5, 2015 | TE: | AB | RLD: | No | ||||
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