Details for New Drug Application (NDA): 200678
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NDA 200678 describes KOMBIGLYZE XR, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the KOMBIGLYZE XR profile page.
The generic ingredient in KOMBIGLYZE XR 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 KOMBIGLYZE XR 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 200678
| Tradename: | KOMBIGLYZE XR |
| Applicant: | Astrazeneca Ab |
| Ingredient: | metformin hydrochloride; saxagliptin hydrochloride |
| Patents: | 2 |
Pharmacology for NDA: 200678
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 200678
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6125 | 0310-6125-60 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6125-60) |
| KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6135 | 0310-6135-30 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0310-6135-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 500MG;EQ 5MG BASE | ||||
| Approval Date: | Nov 5, 2010 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 13, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 13, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 1GM;EQ 5MG BASE | ||||
| Approval Date: | Nov 5, 2010 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 13, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 200678
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-001 | Nov 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-003 | Nov 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-002 | Nov 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| Astrazeneca Ab | KOMBIGLYZE XR | metformin hydrochloride; saxagliptin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200678-001 | Nov 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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