Details for New Drug Application (NDA): 205980
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The generic ingredient in SAXAGLIPTIN is metformin hydrochloride; saxagliptin hydrochloride. There are forty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; saxagliptin hydrochloride profile page.
Summary for 205980
Tradename: | SAXAGLIPTIN |
Applicant: | Mylan |
Ingredient: | saxagliptin hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 205980
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 205980
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SAXAGLIPTIN | saxagliptin hydrochloride | TABLET;ORAL | 205980 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4705 | 0378-4705-77 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-77) |
SAXAGLIPTIN | saxagliptin hydrochloride | TABLET;ORAL | 205980 | ANDA | Mylan Pharmaceuticals Inc. | 0378-4705 | 0378-4705-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4705-93) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Jul 31, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Jul 31, 2023 | TE: | AB | RLD: | No |
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