Details for New Drug Application (NDA): 077337
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NDA 077337 describes ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Teva and is included in one NDA. Additional details are available on the ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE profile page.
The generic ingredient in ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE 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 AND METFORMIN HYDROCHLORIDE 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 077337
| Tradename: | ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE |
| Applicant: | Teva |
| Ingredient: | metformin hydrochloride; rosiglitazone maleate |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG;EQ 2MG BASE | ||||
| Approval Date: | May 7, 2014 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG;EQ 4MG BASE | ||||
| Approval Date: | May 7, 2014 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 1GM;EQ 2MG BASE | ||||
| Approval Date: | May 7, 2014 | TE: | RLD: | No | |||||
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