Details for New Drug Application (NDA): 207209
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NDA 207209 describes REPAGLINIDE, which is a drug marketed by Actavis Totowa, Aurobindo Pharma Ltd, Chartwell Rx, Kenton, Macleods Pharms Ltd, Norvium Bioscience, Padagis Us, Sun Pharm Inds Inc, and Lupin Ltd, and is included in nine NDAs. It is available from seven suppliers. Additional details are available on the REPAGLINIDE profile page.
The generic ingredient in REPAGLINIDE 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 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 207209
| Tradename: | REPAGLINIDE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | repaglinide |
| Patents: | 0 |
Pharmacology for NDA: 207209
| Mechanism of Action | Potassium Channel Antagonists |
Suppliers and Packaging for NDA: 207209
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REPAGLINIDE | repaglinide | TABLET;ORAL | 207209 | ANDA | Macleods Pharmaceuticals Limited | 33342-248 | 33342-248-11 | 100 TABLET in 1 BOTTLE (33342-248-11) |
| REPAGLINIDE | repaglinide | TABLET;ORAL | 207209 | ANDA | Macleods Pharmaceuticals Limited | 33342-248 | 33342-248-44 | 1000 TABLET in 1 BOTTLE (33342-248-44) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Mar 22, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Mar 22, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Mar 22, 2023 | TE: | AB | RLD: | No | ||||
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