Details for New Drug Application (NDA): 205544
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NDA 205544 describes NATEGLINIDE, which is a drug marketed by Alvogen, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Rising, Strides Pharma, Teva Pharms, Watson Labs, and Zydus Pharms, and is included in eight NDAs. It is available from eleven suppliers. Additional details are available on the NATEGLINIDE profile page.
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.
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 205544
| Tradename: | NATEGLINIDE |
| Applicant: | Rising |
| Ingredient: | nateglinide |
| Patents: | 0 |
Pharmacology for NDA: 205544
| Mechanism of Action | Potassium Channel Antagonists |
Suppliers and Packaging for NDA: 205544
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NATEGLINIDE | nateglinide | TABLET;ORAL | 205544 | ANDA | Rising Pharmaceuticals, Inc. | 16571-758 | 16571-758-01 | 100 TABLET in 1 BOTTLE (16571-758-01) |
| NATEGLINIDE | nateglinide | TABLET;ORAL | 205544 | ANDA | Rising Pharmaceuticals, Inc. | 16571-758 | 16571-758-09 | 90 TABLET in 1 BOTTLE (16571-758-09) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Jun 18, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 120MG | ||||
| Approval Date: | Jun 18, 2018 | TE: | AB | RLD: | No | ||||
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