Details for New Drug Application (NDA): 076747
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NDA 076747 describes ROSIGLITAZONE MALEATE, which is a drug marketed by Ani Pharms, Teva Pharms Usa, and Teva, and is included in three NDAs. Additional details are available on the ROSIGLITAZONE MALEATE profile page.
The generic ingredient in ROSIGLITAZONE MALEATE is metformin hydrochloride; rosiglitazone maleate. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.
The generic ingredient in ROSIGLITAZONE MALEATE is metformin hydrochloride; rosiglitazone maleate. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; rosiglitazone maleate profile page.
Summary for 076747
| Tradename: | ROSIGLITAZONE MALEATE |
| Applicant: | Ani Pharms |
| Ingredient: | rosiglitazone maleate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Jan 25, 2013 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Jan 25, 2013 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 8MG BASE | ||||
| Approval Date: | Jan 25, 2013 | TE: | RLD: | No | |||||
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