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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Novartis Pharmaceuticals Corporation to the U.S. FDA. Original Data : FDA Website

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01 2(2'-HYDROXY-5-METHYLPHENYL) BENZOTRIAZOLE (1)

02 5-FU THERAPEUTIC IMPLANT (1)

03 ADJUVANT CGP 11637:TOXICITY STUDIES & RESULTS CONDUCTED IN EUROPEAN FA (1)

04 AL-721 (1)

05 ANAFRANIL INJECTABLE (CLOMIPRAMINE HCl) (1)

06 CGP 17,582B (1)

07 CGP LL637 ADJUVANT--CHEMISTRY & GMP (1)

08 CHLORHEXIDINE GLUCONATE (1)

09 CHLORTHALIDONE USP (1)

10 DAROIL INVESTIGATORS (1)

11 EUDRAGITr RL/RS (1)

12 FACILITIES AND CONTROLS (1)

13 FACILITY AND OPERATING PROCEDURES IN DORVAL, QUEBEC, CANADA (1)

14 FLUVASTATIN DRUG SUBSTANCE (1)

15 KIT FOR PREPARATION OF 99M TC-RHANNEXIN V-128 (1)

16 LAMPRENE (CLOFAZIMINE) AS PRODUCED IN CAPSULE FORM (1)

17 LIORESAL INTRATHECAL AMPULS/BACLOFEN (1)

18 LUTETIUM [177 LU] TRICHLORIDE (1)

19 LYSINE HYDROCHLORIDE (HCI)-ARGININE HYDROCHLORIDE (HCI), 2.5%, SOLUTION (1)

20 MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING PROCEDURES IN STEIN, SWITZERLAND. (1)

21 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURE IN ORLEANS-LA SOURCE, FRANCE. (1)

22 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GRIMSBY, UK (1)

23 NAFTIFINE HYDROCHLORIDE (1)

24 NAPHAZOLINE HYDROCHLORIDE (1)

25 NEVIRAPINE ANHYDROUS USP (1)

26 PENTETREOTIDE (1)

27 PERSONNEL, FACILS & GEN OPERATING PROCEDURES AT EAST HANOVER, NJ. (1)

28 POLY (DL-LACTIDE-CO-GLYCOLIDE) (1)

29 PULMONARY DRUG DELIVERY SYSTEM (PDDS) CLINICAL (1)

30 PULMOSPHERE(R) PLACEBO INHALATION POWDER (1)

31 PYRILAMINE BASE (1)

32 PYRILAMINE MALEATE (1)

33 RIFAMPIN (1)

34 RITALIN (1)

35 SIPON (MLS) MAGNESIUM LAURYL SULFATE (1)

36 SMT487 ACETATE (EDOTREOTIDE) (1)

37 STARTING MATERIALS 1 & 3, IN NEW JERSEY AND SWITZERLAND (1)

38 STEROID/ANTI-INFECTIVE OPHTH.COMBINATIONS;SAFETY/EFFICACY ANALYSIS (1)

39 TERBINAFINE (1)

40 TESSALON DRUG SUBSTANCE (1)

41 TESSALON DRUG SUBSTANCE, (BENZONATATE, USP) (1)

42 TINOSORB(TM) MBBT (1)

43 TINUVIN 326 (1)

44 TOPOTECAN HYDROCHLORIDE (1)

45 TRAFURIL(THURFYL NICOTINATE)MNFG BY CIBA LABS,TESTED IN BASIL (1)

46 VALSARTAN DRUG SUBSTANCE (1)

47 ZIDOVUDINE USP (1)

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01 ADVANCED ACCELERATOR APPLICATIONS USA INC (3)

02 ALCOLAC INC (2)

03 ALCON LABORATORIES INC (3)

04 CIBA GEIGY CORP (1)

05 CIBA GEIGY CORP PHARMACEUTICAL DIV (1)

06 CIBA GEIGY CORP PHARMACEUTICAL DIVISION (4)

07 CIBA GEIGY LTD (4)

08 CIBA PHARMACEUTICAL CO DIV CIBA GEIGY CORP (1)

09 CIBA SPECIALTY CHEMICALS (2)

10 MATRIX PHARMA GROUP XIAMEN LTD (2)

11 MATRIX PHARMACEUTICAL INC (1)

12 MATRIX RESEARCH LABORATORIES INC (1)

13 NOVARTIS (1)

14 NOVARTIS PHARMA AG (4)

15 NOVARTIS PHARMACEUTICALS CORP (17)

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01 France (3)

02 Switzerland (35)

03 U.S.A (9)

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01 Active (9)

02 Inactive (38)

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01 Blank (47)

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CIBA GEIGY CORP PHARM...
Inactive
4583
N/A
1982-06-15
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ALCOLAC INC
Inactive
6987
N/A
1987-05-19
II
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CIBA GEIGY LTD
Inactive
6910
N/A
1987-03-26
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CIBA GEIGY CORP PHARM...
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7810
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1988-12-20
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NOVARTIS PHARMACEUTIC...
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23901
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2010-06-30
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CIBA GEIGY CORP PHARM...
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3527
N/A
1979-05-04
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NOVARTIS PHARMACEUTIC...
Active
9643
N/A
1992-04-15
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ADVANCED ACCELERATOR ...
Active
31705
N/A
2017-05-02
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ADVANCED ACCELERATOR ...
Inactive
31023
N/A
2016-09-26
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NOVARTIS PHARMA AG
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16772
N/A
2003-08-19
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