ANTIBIOTICOS

Overview

ANTIBIOTICOS is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering 6-AMINO PENICILLANIC ACID; AMOXICILLIN; AMPICILLIN TRIHYDRATE; CEPHALEXIN MONOHYDRATE.

API / Drug Master Files

ANTIBIOTICOS holds 4 active (13 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.

• CEPHALEXIN MONOHYDRATEActive1998-09-01
• AMOXICILLINActive1998-09-01
• AMPICILLIN TRIHYDRATEActive1998-09-01
• 6-AMINO PENICILLANIC ACIDActive1997-01-31
• 7-AMINO-DEACETOXY-CEPHALOSPORANIC ACID (7ADCA)Inactive2002-01-28
• CANDICIDINInactive1998-09-01
• CEPHALEXIN MONOHYDRATEInactive1998-09-01
• CLOXACILLIN SODIUMInactive1998-09-01
• CEPHALOTHIN SODIUM;SODIUM CHLORIDEInactive1998-09-01
• CEPHALOTHIN SODIUM;SODIUM CHLORIDEInactive1998-09-01
• TETRACYCLINE PHOSPHATE COMPLEXInactive1998-09-01
• PENICILLIN G POTASSIUMInactive1998-09-01
• MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES FOR BULK PROCESS DEVELOPMENT IN RODANO, ITALY.Inactive1995-07-20

FDA compliance signals

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