Details for New Drug Application (NDA): 207678
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NDA 207678 describes METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE, which is a drug marketed by Dr Reddys Labs Sa and is included in one NDA. It is available from one supplier. Additional details are available on the METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE profile page.
The generic ingredient in METFORMIN HYDROCHLORIDE; SAXAGLIPTIN 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 METFORMIN HYDROCHLORIDE; SAXAGLIPTIN 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 207678
| Tradename: | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE |
| Applicant: | Dr Reddys Labs Sa |
| Ingredient: | metformin hydrochloride; saxagliptin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 207678
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 207678
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 207678 | ANDA | Dr.Reddys Laboratories Inc | 43598-618 | 43598-618-60 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-618-60) |
| METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 207678 | ANDA | Dr.Reddys Laboratories Inc | 43598-619 | 43598-619-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (43598-619-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG;EQ 5MG BASE | ||||
| Approval Date: | Aug 9, 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: | Aug 9, 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: | Aug 9, 2023 | TE: | AB | RLD: | No | ||||
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