Details for New Drug Application (NDA): 208449
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NDA 208449 describes LINAGLIPTIN AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Sunshine and Zydus Pharms and is included in two NDAs. Additional details are available on the LINAGLIPTIN AND METFORMIN HYDROCHLORIDE profile page.
The generic ingredient in LINAGLIPTIN AND METFORMIN HYDROCHLORIDE is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.
The generic ingredient in LINAGLIPTIN AND METFORMIN HYDROCHLORIDE is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.
Summary for 208449
| Tradename: | LINAGLIPTIN AND METFORMIN HYDROCHLORIDE |
| Applicant: | Zydus Pharms |
| Ingredient: | linagliptin; metformin hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG;500MG | ||||
| Approval Date: | Mar 30, 2023 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG;850MG | ||||
| Approval Date: | Mar 30, 2023 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 2.5MG;1GM | ||||
| Approval Date: | Mar 30, 2023 | TE: | RLD: | No | |||||
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