Details for New Drug Application (NDA): 205981
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NDA 205981 describes SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Sa, Mylan, and Sun Pharm, and is included in three NDAs. It is available from two suppliers. Additional details are available on the SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE profile page.
The generic ingredient in SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE 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.
The generic ingredient in SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE 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 205981
| Tradename: | SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE |
| Applicant: | Mylan |
| Ingredient: | metformin hydrochloride; saxagliptin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 205981
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 205981
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205981 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8175 | 0378-8175-93 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8175-93) |
| SAXAGLIPTIN AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 205981 | ANDA | Mylan Pharmaceuticals Inc. | 0378-8176 | 0378-8176-91 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-8176-91) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG;EQ 5MG BASE | ||||
| Approval Date: | Jul 31, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM;EQ 2.5MG BASE | ||||
| Approval Date: | Jul 31, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM;EQ 5MG BASE | ||||
| Approval Date: | Jul 31, 2023 | TE: | AB | RLD: | No | ||||
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