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GLYBURIDE (MICRONIZED)

ANDA

GLYBURIDE | A075890 | HIKMA PHARMACEUTICALS

3 strengths0 unique patents0 unique exclusivities

API Supply Chain7 active DMFs9 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

CAMBREX PROFARMACO MILANO SRLGLYBURIDE

DMF 76751988

USV PRIVATE LTDGLYBURIDE USP

DMF 158212002

CADILA PHARMACEUTICALS LTDGLYBURIDE USP

DMF 170932004

APITORIA PHARMA PRIVATE LTDGLYBURIDE USP

DMF 171522004

ZENTIVA KSGLYBURIDE USP (GLIBENCLAMIDE), MILLED

DMF 180182005

SRI KRISHNA PHARMACEUTICALS LTDGLYBURIDE USP

DMF 270452013

TIANJIN PHARMACEUTICAL HOLDINGS GENCOM PHARMACY CO LTDGLYBURIDE

DMF 299212015

FARMOS GROUP LTD MEDIPOLARInactiveGLYBURIDE

DMF 76381988

CADILA LABORATORIES PVT LTDInactiveGLYBURIDE BP'88 (GLIBENCLAMIDE)

DMF 79891989

SELOC FRANCEInactiveGLYBURIDE

DMF 110551994

HOECHST CELANESE CORPInactiveGLYBURIDE

DMF 111791994

AVENTIS PHARMA DEUTSCHLAND GMBHInactiveGLYBURIDE [MILLED (GROUND)]

DMF 121361996

AVENTIS PHARMA DEUTSCHLAND GMBHInactiveGLYBURIDE (MICRONIZED) BULK DRUG SUBSTANCE

DMF 121651996

USV LTDInactiveGLYBURIDE

DMF 143391999

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveGLYBURIDE USP

DMF 182662005

CADILA HEALTHCARE LTDInactiveGLYBURIDE

DMF 192362006

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 10, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1.5MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 31, 2003

No patent or exclusivity listings for this strength.

#002 — 3MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 31, 2003

#003 — 6MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 31, 2003