Details for New Drug Application (NDA): 077462
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The generic ingredient in NATEGLINIDE is nateglinide. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nateglinide profile page.
Summary for 077462
Tradename: | NATEGLINIDE |
Applicant: | Watson Labs |
Ingredient: | nateglinide |
Patents: | 0 |
Pharmacology for NDA: 077462
Mechanism of Action | Potassium Channel Antagonists |
Suppliers and Packaging for NDA: 077462
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NATEGLINIDE | nateglinide | TABLET;ORAL | 077462 | ANDA | Actavis Pharma, Inc. | 0591-3354 | 0591-3354-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-3354-01) |
NATEGLINIDE | nateglinide | TABLET;ORAL | 077462 | ANDA | Actavis Pharma, Inc. | 0591-3355 | 0591-3355-01 | 100 TABLET in 1 BOTTLE, PLASTIC (0591-3355-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Mar 30, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
Approval Date: | Mar 30, 2011 | TE: | AB | RLD: | No |
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