W R GRACE AND CO -CONN

Overview

W R GRACE AND CO -CONN is an active pharmaceutical ingredient (API) supplier with 16 active FDA Type II Drug Master Files, covering BENAZEPRIL HYDROCHLORIDE; BENZONATATE USP; DIPHENHYDRAMINE CITRATE, USP; FENOPROFEN CALCIUM, USP+BP; FLURBIPROFEN USP & BP; ITRACONAZOLE USP & PH EUR.

API / Drug Master Files

W R GRACE AND CO -CONN holds 16 active (20 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.

• BENAZEPRIL HYDROCHLORIDEActive2000-02-21
• MILRINONE USPActive1999-08-31
• PRAMOXINE HYDROCHLORIDEActive1998-09-24
• TERCONAZOLEActive1998-02-19
• ITRACONAZOLE USP & PH EURActive1997-10-16
• FLURBIPROFEN USP & BPActive1996-03-26
• LIDOCAINE USPActive1995-06-05
• DIPHENHYDRAMINE CITRATE, USPActive1994-09-23
• TETRACAINE HCLActive1989-09-21
• FENOPROFEN CALCIUM, USP+BPActive1987-03-03
• PROPRANOLOL HYDROCHLORIDEActive1985-06-05
• ORPHENADRINE CITRATE USPActive1985-02-22
• MECLOFENAMATE SODIUM USPActive1984-11-13
• BENZONATATE USPActive1983-12-13
• PROCAINAMIDE HYDROCHLORIDEActive1983-04-18

Showing 15 of 20 Drug Master Files.

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to W R GRACE AND CO -CONN in our records. PharmaTek screens the full directory against live FDA enforcement data.