Details for New Drug Application (NDA): 204144
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NDA 204144 describes SITAGLIPTIN AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Ph Health, Apotex, and Sandoz, and is included in three NDAs. It is available from three suppliers. Additional details are available on the SITAGLIPTIN AND METFORMIN HYDROCHLORIDE profile page.
The generic ingredient in SITAGLIPTIN AND METFORMIN HYDROCHLORIDE is metformin hydrochloride; sitagliptin phosphate. There are forty-nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.
The generic ingredient in SITAGLIPTIN AND METFORMIN HYDROCHLORIDE is metformin hydrochloride; sitagliptin phosphate. There are forty-nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.
Summary for 204144
| Tradename: | SITAGLIPTIN AND METFORMIN HYDROCHLORIDE |
| Applicant: | Ph Health |
| Ingredient: | metformin hydrochloride; sitagliptin phosphate |
| Patents: | 0 |
Pharmacology for NDA: 204144
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 204144
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 204144 | ANDA | Par Health USA, LLC | 10370-317 | 10370-317-02 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (10370-317-02) |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | metformin hydrochloride; sitagliptin phosphate | TABLET, EXTENDED RELEASE;ORAL | 204144 | ANDA | Par Health USA, LLC | 10370-318 | 10370-318-02 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (10370-318-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG;EQ 50MG BASE | ||||
| Approval Date: | Jun 4, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM;EQ 50MG BASE | ||||
| Approval Date: | Jun 4, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM;EQ 100MG BASE | ||||
| Approval Date: | Jun 4, 2025 | TE: | AB | RLD: | No | ||||
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