NOVITIUM PHARMA LLC

Overview

NOVITIUM PHARMA LLC is an active pharmaceutical ingredient (API) supplier with 12 active FDA Type II Drug Master Files, covering BETAINE ANHYDROUS; CARGLUMIC ACID; DAPSONE USP; DIAZOXIDE USP; DICHLORPHENAMIDE USP; FLUDROCORTISONE ACETATE USP.

API / Drug Master Files

NOVITIUM PHARMA LLC holds 12 active (12 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.

• FLUDROCORTISONE ACETATE USPActive2020-06-09
• BETAINE ANHYDROUSActive2020-03-12
• METHYLTESTOSTERONE USPActive2019-12-17
• DICHLORPHENAMIDE USPActive2019-12-10
• LEVORPHANOL TARTRATE USPActive2018-12-31
• CARGLUMIC ACIDActive2018-12-07
• OXANDROLONE USPActive2017-10-28
• THIOTHIXENE USPActive2017-07-21
• PRAZOSIN HYDROCHLORIDE USPActive2017-06-16
• DIAZOXIDE USPActive2017-01-27
• NITISINONEActive2017-01-02
• DAPSONE USPActive2013-12-13

FDA compliance signals

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