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Details for New Drug Application (NDA): 075795

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NDA 075795 describes GLIPIZIDE, which is a drug marketed by Sandoz, Barr Labs Inc, Sun Pharm Inds Inc, Watson Labs, Mylan, Accord Hlthcare, Par Pharm, Vintage Pharms Llc, Ani Pharms Inc, Apotex, Mylan Pharms Inc, Zydus Pharms Usa Inc, Corepharma, Heritage Pharms Inc, and Teva Pharms, and is included in twenty-two NDAs. It is available from forty-six suppliers. Additional details are available on the GLIPIZIDE profile page.

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

Summary for NDA: 075795

Tradename:
GLIPIZIDE
Applicant:
Apotex
Ingredient:
glipizide
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 075795

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 075795

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIPIZIDE
glipizide
TABLET;ORAL 075795 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7968 0615-7968-05 15 TABLET in 1 BLISTER PACK (0615-7968-05)
GLIPIZIDE
glipizide
TABLET;ORAL 075795 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7968 0615-7968-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7968-30) > 5 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jun 13, 2001TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 13, 2001TE:ABRLD:No


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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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