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Last Updated: October 16, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206483


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NDA 206483 describes GLYBURIDE, which is a drug marketed by Actavis Elizabeth, Aurobindo Pharma, Cadila Pharms Ltd, Epic Pharma Llc, Heritage Pharms Inc, Impax Labs Inc, Orient Pharma Co Ltd, Swiss Pharm, Teva, Zydus Pharms, Dava Pharms Inc, Hikma, Mylan, Sanofi Aventis Us, and Yaopharma Co Ltd, and is included in twenty-three NDAs. It is available from twenty-one suppliers. Additional details are available on the GLYBURIDE profile page.

The generic ingredient in GLYBURIDE is glyburide; metformin hydrochloride. There are twenty drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the glyburide; metformin hydrochloride profile page.
Summary for 206483
Tradename:GLYBURIDE
Applicant:Orient Pharma Co Ltd
Ingredient:glyburide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206483
Medical Subject Heading (MeSH) Categories for 206483
Suppliers and Packaging for NDA: 206483
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE glyburide TABLET;ORAL 206483 ANDA Pharmaceutical Associates, Inc. 0121-0929 0121-0929-90 100 TABLET in 1 BOTTLE (0121-0929-90)
GLYBURIDE glyburide TABLET;ORAL 206483 ANDA Pharmaceutical Associates, Inc. 0121-0929 0121-0929-91 500 TABLET in 1 BOTTLE (0121-0929-91)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.25MG
Approval Date:Feb 22, 2019TE:AB1RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Feb 22, 2019TE:AB1RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Feb 22, 2019TE:AB1RLD:No

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