Details for New Drug Application (NDA): 022350
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NDA 022350 describes ONGLYZA, which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ONGLYZA profile page.
The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.
The generic ingredient in ONGLYZA is saxagliptin hydrochloride. There are fifteen drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the saxagliptin hydrochloride profile page.
Summary for 022350
| Tradename: | ONGLYZA |
| Applicant: | Astrazeneca Ab |
| Ingredient: | saxagliptin hydrochloride |
| Patents: | 1 |
Pharmacology for NDA: 022350
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 022350
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6100 | 0310-6100-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6100-30) |
| ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350 | NDA | AstraZeneca Pharmaceuticals LP | 0310-6100 | 0310-6100-90 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-6100-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 31, 2009 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Nov 30, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Jul 31, 2009 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Nov 30, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022350
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-001 | Jul 31, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-002 | Jul 31, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| Astrazeneca Ab | ONGLYZA | saxagliptin hydrochloride | TABLET;ORAL | 022350-002 | Jul 31, 2009 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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