Details for New Drug Application (NDA): 203820
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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 203820
Tradename: | REPAGLINIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | repaglinide |
Patents: | 0 |
Pharmacology for NDA: 203820
Mechanism of Action | Potassium Channel Antagonists |
Suppliers and Packaging for NDA: 203820
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
REPAGLINIDE | repaglinide | TABLET;ORAL | 203820 | ANDA | Rising Pharma Holdings, Inc. | 57237-157 | 57237-157-01 | 100 TABLET in 1 BOTTLE (57237-157-01) |
REPAGLINIDE | repaglinide | TABLET;ORAL | 203820 | ANDA | Rising Pharma Holdings, Inc. | 57237-157 | 57237-157-05 | 500 TABLET in 1 BOTTLE (57237-157-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Jan 22, 2014 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Jan 22, 2014 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Jan 22, 2014 | TE: | AB | RLD: | No |
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