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Generated: May 20, 2019

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Details for New Drug Application (NDA): 075890

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NDA 075890 describes GLYBURIDE (MICRONIZED), which is a drug marketed by Dava Pharms Inc, Hikma, Mylan, Sanofi Aventis Us, Teva, and Yaopharma Co Ltd, and is included in six NDAs. It is available from eight suppliers. Additional details are available on the GLYBURIDE (MICRONIZED) profile page.

The generic ingredient in GLYBURIDE (MICRONIZED) is glyburide. There are twenty drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the glyburide profile page.
Summary for 075890
Tradename:GLYBURIDE (MICRONIZED)
Applicant:Hikma
Ingredient:glyburide
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075890
Medical Subject Heading (MeSH) Categories for 075890
Suppliers and Packaging for NDA: 075890
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 075890 ANDA Hikma Pharmaceuticals USA Inc. 0143-9918 0143-9918-01 100 TABLET in 1 BOTTLE, PLASTIC (0143-9918-01)
GLYBURIDE (MICRONIZED) glyburide TABLET;ORAL 075890 ANDA Hikma Pharmaceuticals USA Inc. 0143-9918 0143-9918-05 500 TABLET in 1 BOTTLE, PLASTIC (0143-9918-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1.5MG
Approval Date:Jul 31, 2003TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG
Approval Date:Jul 31, 2003TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength6MG
Approval Date:Jul 31, 2003TE:ABRLD:No

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