Serving 500+ biopharmaceutical companies globally:
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Serving 500+ biopharmaceutical companies globally:
Generated: July 22, 2017
| Tradename: | 1 |
| Applicant: | 1 |
| Ingredient: | 1 |
| Patents: | 1 |
| Formulation / Manufacturing: | see details |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
| 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) |
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Jul 31, 2009 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 27, 2020 | ||||||||
| Regulatory Exclusivity Use: | |||||||||
| Patent: | 7,951,400 | Patent Expiration: | Nov 30, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Regulatory Exclusivity Expiration: | Apr 5, 2019 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING DESCRIBING SAVOR, A PHASE IV TRIAL EVALUATING THE EFFECT OF SAXAGLIPTIN ON THE INCIDENCE OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION OR ISCHAEMIC STROKE IN PATIENTS WITH TYPE 2 DIABETES | ||||||||
Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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