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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Cipla
US Department of Justice
Teva
Merck
US Army
McKinsey
QuintilesIMS
Dow
Mallinckrodt

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202298

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NDA 202298 describes GLIPIZIDE, which is a drug marketed by Sandoz, Barr Labs Inc, Unique Pharm Labs, Sun Pharm Inds Inc, Watson Labs Teva, Mylan, Aurobindo Pharma Ltd, Accord Hlthcare, Par Pharm, Watson Labs, Vintage Pharms Llc, Ani Pharms Inc, Apotex, Mylan Pharms Inc, Zydus Pharms Usa Inc, Epic Pharma Llc, Heritage Pharms Inc, and Teva Pharms, and is included in twenty-four NDAs. It is available from fifty-four 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. Fifteen suppliers are listed for this compound. Additional details are available on the glipizide; metformin hydrochloride profile page.

Summary for NDA: 202298

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for NDA: 202298

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 202298

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIPIZIDE
glipizide
TABLET, EXTENDED RELEASE;ORAL 202298 ANDA Mylan Pharmaceuticals Inc. 0378-0340 0378-0340-93 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0340-93)
GLIPIZIDE
glipizide
TABLET, EXTENDED RELEASE;ORAL 202298 ANDA Mylan Pharmaceuticals Inc. 0378-0342 0378-0342-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-0342-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2.5MG
Approval Date:May 19, 2015TE:ABRLD:No
Regulatory Exclusivity Expiration:Jul 27, 2016
Regulatory Exclusivity Use:PATENT CHALLENGE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:May 19, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:May 19, 2015TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Colorcon
US Army
Daiichi Sankyo
QuintilesIMS
Fuji
Argus Health
Moodys
Express Scripts
Queensland Health

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