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Details for New Drug Application (NDA): 076159

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NDA 076159 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: 076159

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

Pharmacology for NDA: 076159

Ingredient-typeSulfonylurea Compounds

Suppliers and Packaging for NDA: 076159

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLIPIZIDE
glipizide
TABLET, EXTENDED RELEASE;ORAL 076159 ANDA Par Pharmaceutical, Inc. 49884-745 49884-745-01 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (49884-745-01)
GLIPIZIDE
glipizide
TABLET, EXTENDED RELEASE;ORAL 076159 ANDA Par Pharmaceutical, Inc. 49884-745 49884-745-05 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (49884-745-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength10MG
Approval Date:Sep 20, 2013TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength5MG
Approval Date:Sep 20, 2013TE:ABRLD:No


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