Details for New Drug Application (NDA): 200624
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NDA 200624 describes REPAGLINIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Lupin Ltd and is included in one NDA. Additional details are available on the REPAGLINIDE AND METFORMIN HYDROCHLORIDE profile page.
The generic ingredient in REPAGLINIDE AND METFORMIN HYDROCHLORIDE is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.
The generic ingredient in REPAGLINIDE AND METFORMIN HYDROCHLORIDE is metformin hydrochloride; repaglinide. There are forty-nine drug master file entries for this compound. Additional details are available on the metformin hydrochloride; repaglinide profile page.
Summary for 200624
| Tradename: | REPAGLINIDE AND METFORMIN HYDROCHLORIDE |
| Applicant: | Lupin Ltd |
| Ingredient: | metformin hydrochloride; repaglinide |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG;1MG | ||||
| Approval Date: | Jul 15, 2015 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG;2MG | ||||
| Approval Date: | Jul 15, 2015 | TE: | RLD: | No | |||||
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