ZENTIVA KS

Overview

ZENTIVA KS is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering ARTICAINE HYDROCHLORIDE; GLYBURIDE USP (GLIBENCLAMIDE), MILLED.

API / Drug Master Files

ZENTIVA KS holds 2 active (6 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• ARTICAINE HYDROCHLORIDEActive2007-02-20
• GLYBURIDE USP (GLIBENCLAMIDE), MILLEDActive2005-01-21
• TAMSULOSIN HYDROCHLORIDEInactive2005-03-14
• ZOLPIDEM TARTRATEInactive2003-06-02
• TETRAHYDROZOLINE HYDROCHLORIDE USPInactive2000-12-15
• METOPROLOL SUCCINATEInactive1995-08-15

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to ZENTIVA KS in our records. PharmaTek screens the full directory against live FDA enforcement data.