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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078728

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NDA 078728 describes GLIPIZIDE AND METFORMIN HYDROCHLORIDE, which is a drug marketed by Epic Pharma Llc, Heritage Pharms Inc, Mylan, Sun Pharm Inds Inc, Teva Pharms, and Zydus Pharms Usa Inc, and is included in six NDAs. It is available from fifteen suppliers. Additional details are available on the GLIPIZIDE AND METFORMIN HYDROCHLORIDE profile page.

The generic ingredient in GLIPIZIDE AND METFORMIN HYDROCHLORIDE is glipizide; metformin hydrochloride. There are eighteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.

Summary for 078728

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 078728

Suppliers and Packaging for NDA: 078728

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 078728 ANDA Heritage Pharmaceuticals Inc. 23155-115 23155-115-01 100 TABLET, FILM COATED in 1 BOTTLE (23155-115-01)
GLIPIZIDE AND METFORMIN HYDROCHLORIDE glipizide; metformin hydrochloride TABLET;ORAL 078728 ANDA Heritage Pharmaceuticals Inc. 23155-115 23155-115-10 1000 TABLET, FILM COATED in 1 BOTTLE (23155-115-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;250MG
Approval Date:Jun 23, 2010TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG;500MG
Approval Date:Jun 23, 2010TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG;500MG
Approval Date:Jun 23, 2010TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

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UBS

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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