Details for New Drug Application (NDA): 205248
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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 205248
Tradename: | NATEGLINIDE |
Applicant: | Zydus Pharms |
Ingredient: | nateglinide |
Patents: | 0 |
Pharmacology for NDA: 205248
Mechanism of Action | Potassium Channel Antagonists |
Suppliers and Packaging for NDA: 205248
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NATEGLINIDE | nateglinide | TABLET;ORAL | 205248 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-721 | 68382-721-01 | 100 TABLET, FILM COATED in 1 BOTTLE (68382-721-01) |
NATEGLINIDE | nateglinide | TABLET;ORAL | 205248 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-721 | 68382-721-05 | 500 TABLET, FILM COATED in 1 BOTTLE (68382-721-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Jul 6, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
Approval Date: | Jul 6, 2016 | TE: | AB | RLD: | No |
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