Details for New Drug Application (NDA): 078709
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NDA 078709 describes ROSIGLITAZONE MALEATE AND GLIMEPIRIDE, which is a drug marketed by Teva Pharms Usa and is included in one NDA. Additional details are available on the ROSIGLITAZONE MALEATE AND GLIMEPIRIDE profile page.
The generic ingredient in ROSIGLITAZONE MALEATE AND GLIMEPIRIDE is glimepiride; rosiglitazone maleate. There are sixteen drug master file entries for this compound. Additional details are available on the glimepiride; rosiglitazone maleate profile page.
The generic ingredient in ROSIGLITAZONE MALEATE AND GLIMEPIRIDE is glimepiride; rosiglitazone maleate. There are sixteen drug master file entries for this compound. Additional details are available on the glimepiride; rosiglitazone maleate profile page.
Summary for 078709
| Tradename: | ROSIGLITAZONE MALEATE AND GLIMEPIRIDE |
| Applicant: | Teva Pharms Usa |
| Ingredient: | glimepiride; rosiglitazone maleate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1MG;4MG | ||||
| Approval Date: | Apr 1, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2MG;4MG | ||||
| Approval Date: | Apr 1, 2016 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 4MG;4MG | ||||
| Approval Date: | Apr 1, 2016 | TE: | RLD: | No | |||||
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