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

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01 'ZENTEL' 'TILTAB' TABLETS (1)

02 0/4 DIHYDROCHLORIDE DIHYDRATE (CEPHALORIDINE ROUTE-CP)-ULVERSTON PLANT (1)

03 5-IODO-2-DEOXYURIDINE (IUDR) (1)

04 6-AMINO PENICILLANIC ACID (2)

05 6-AMINOPENICILLANIC ACID (1)

06 6-AMINOPENICILLANIC ACID [6-APA] (1)

07 7-ACA TOSYLATE (1)

08 ALBENDAZOLE (1)

09 ALBUTEROL (1)

10 ALBUTEROL (SALBUTAMOL) AS PRODUCTED IN THE MONTROSE,SCOTLAND FACILITY (1)

11 AMOXICILLIN SODIUM (1)

12 AMOXICILLIN TRIHYDRATE (4)

13 AMPICILLIN (1)

14 AMPICILLIN SODIUM (1)

15 AMPICILLIN TRIHYDRATE (3)

16 APSAC (ANISOYLATED PLASMINOGEN STREPTOKINASE COMPLEX - BRL26921) (1)

17 ASO1B ADJUVANT SYSTEM (1)

18 AURANOFIN (1)

19 BANDING OF PSEUDOEPHEDRINE HCl AND CHLORPHENIRAMINE MALEATE (1)

20 BETAMETHASONE DIPROPIONATE PRODUCED IN THE MONTROSE, SCOTLAND PLANT (1)

21 BETAMETHASONE VALERATE (1)

22 BRL 47539 (2-ACETOXYMETHYL-4-IODOBUT-1-YL-ACETATE) (2)

23 BUILDINGS AND FACILITIES IN SEALS SANDS, ENGLAND (1)

24 CALCITONIN (1)

25 CARAMIPHEN EDISYLATE (1)

26 CARBENICILLIN INDANYL SODIUM (1)

27 CARBON-14 ALBENDAZOLE SUSPENSION (1)

28 CEFTAZIDIME (1)

29 CEFTAZIDIME PENTAHYDRATE BULK DRUG SUBSTANCE (1)

30 CEFUROXIME AXETIL BULK DRUG SUBSTANCE (1)

31 CEFUROXIME SODIUM (1)

32 CEPHALEXIN (1)

33 CEPHALOSPORINS FILLING UNIT IN EVREUX, FRANCE (1)

34 CEPHALOSPORINS FILLING UNIT LOC IN BERNARD CASTLE, COUNTY DURHAM ENG. (1)

35 CEPHRADINE (1)

36 CHIMERIC (MACAQUE VARIABLE/HUMAN CONSTANT) (RECOMBINANT, CHO CELLS) MONOCLONAL ANTIBODY (SB 210396; CE9.1) TO HUMAN CD4 ANTIGEN (1)

37 CHLORPHENIRAMINE MALEATE (1)

38 CIMETIDINE (2)

39 CIMETIDINE AND CIMETIDINE HCL (1)

40 CLAVULANATE POTASSIUM (1)

41 CLAVULANATE POTASSIUM STERILE BULK (1)

42 CLAVULANATE POTASSIUM, BULK FORMS (1)

43 CLENOLIXIMAB [CHIMERIC (MACAQUE/HUMAN) MONOCLONAL ANTIBODY (SB-217969) (CHO CELLS, SMITHKLINE BEECHAM) TO CD4] (1)

44 CLOBETASOL PROPIONATE (1)

45 CLOXACILLIN BENZATHINE (3)

46 CLOXACILLIN SODIUM (3)

47 COMPOUND 904 (1)

48 COMPOUND C-205 (1)

49 CYTOMEL IMPLANT PELLETS (VET) (1)

50 DICLOXACILLIN SODIUM MONOHYDRATE (1)

51 DIETHYLCARBAMIZINE CITRATE (1)

52 DIHYDROSTREPTOMYCIN SULFATE (1)

53 DIONOSIL OILY (NDA 9-309) (1)

54 DIPHENIDOL HCL (1)

55 DIPHENYLPYRALINE HCL--PRODUCED IN SMITHKLINE FACILS-CONSHOHOCKEN, PA. (1)

56 DOPAMINE HYDROCHLORIDE (1)

57 DOXEPIN HCL (1)

58 ENTRENOL (1)

59 FACIL, PERSONNEL & GENL OPER PROCED IN GREAT BURGH, EPSOM, U.K. (1)

60 FACIL, PERSONNEL AND GENERAL OPERATING PROCEDURES IN HARLOW, ESSEX. (1)

61 FACILITIES & CONTROLS OF THE WELLCOME FOUNDATION IN KENT ENGLAND (1)

62 FACILITIES AND MANUFACTURING (1)

63 FACILITIES AND OPERATING PROCEDURES IN TIANJIN, CHINA (1)

64 FACILITIES UTILIZED IN WARE HERTS, UNITED KINGDOM (1)

65 FACILITIES&CONTROLS AT HARLOW AND GREAT BURGH RESEARCH SITES, ENGLAND (1)

66 FACILITIES, METHODS AND CONTROLS (1)

67 FACILITY IN BUCKHAVEN, UNITED KINGDOM (1)

68 FACILITY LOCATED IN EDINBURG, SCOTLAND (1)

69 FACILS AND GEN OPER PROCEDS AT THE ULVERSTON PLANT (1)

70 FLUTICASONE FUROATE (1)

71 FLUTICASONE PROPIONATE (2)

72 FONDAPARINUX SODIUM (1)

73 G. FACILITIES LOCATED IN JURONG, SINGAPORE (1)

74 G. SITE FACILITIES UTILIZED IN SPEKE LIVERPOOL (UK) (1)

75 GAMOPHEN (1)

76 GENERAL OPERATING PROCEDURES FOR THE HEPPIGIES, BELGIUM--ANTIBIOTICS (1)

77 GENERAL OPERATING PROCEDURES SINGAPORE PLANT (1)

78 GR, CONTROL PROCEDURES & FACILITIES-MYERSTOWN, PA., PLANT (1)

79 GRISEOFULVIN (1)

80 HIV VACCINE (GPL 120/NEFTA/ASO2A) (1)

81 HYDROCHLOROTHIAZIDE (1)

82 HYDROCHLOROTHIAZIDE IN PHIL PA (1)

83 ISOPROPAMIDE IODIDE (1)

84 L-DM1 (1)

85 LABETALOL HYDROCHLORIDE (1)

86 MANUFACTURING FACILITY AT VERONA, ITALY. (1)

87 MANUFACTURING PRODUCTION FACILITY IN TORONTO, CANADA (1)

88 MANUFACTURING SITE AND FACILITIES FOR ANNAN, UK PLANT (1)

89 MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN SINGAPORE (1)

90 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN BOMBAY, INDIA. (1)

91 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CAROLINA, PUERTO RICO. (2)

92 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CIDRA, PUERTO RICO. (2)

93 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN CUERNAVACA, MEXICO. (1)

94 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN GREENVILLE, NORTH CAROLINA. (1)

95 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MONTROSE, ANGEES, SCOTLAND. (1)

96 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN TONBRIDGE, KENT, ENGLAND. (1)

97 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES. (1)

98 MANUFACTURING SITE, FACILITIES, PESONNEL, AND GENERAL OPERATING PROCEDURES IN WEST SUSSEX, ENGLAND. (1)

99 MEGESTROL ACETATE (1)

100 METHICILLIN SODIUM (2)

101 MUPIROCIN FREE ACID AND MUPIROCIN CALCIUM (NON-STERILE) (1)

102 NAFCILLIN SODIUM (1)

103 O/4 DIHYDROCHLORIDE DIHYRATE (CPZ ROUTE) (1)

104 OXACILLIN SODIUM MONOHYDRATE (1)

105 PAROXETINE HYDROCHLORIDE HEMIHYDRATE (2)

106 PENICILLIN G INTERMEDIATES (1)

107 PENICILLIN G POTASSIUM (3)

108 PENICILLIN G POTASSIUM, NON-STERILE, TECHNICAL GRADE (1)

109 PENN CHEMICALS PRODUCTION FACILITY IN COUNTY CORK, IRELAND (1)

110 PROCESSING OF STERILE BULK CLAVULANATE POTASSIUM (1)

111 SALMETEROL XINAFOATE (1)

112 SKF 385 TRANYLCYPROMINE (VET) (1)

113 STERILE AMOXICILLIN SODIUM (1)

114 STREPTOMYCIN SULFATE (1)

115 SUCRALFATE (1)

116 SULFOXYL (1)

117 SYNTHESIS & QUALITY CONTROLS FOR 5,7-DICHLORO-8-HYDROXYQUINOLONE (1)

118 TICARCILLIN DISODIUM (2)

119 TICARCILLIN DISODIUM BULK (STERILE ) (1)

120 TICARCILLIN MONOSODIUM (1)

121 TICARCILLIN MONOSODIUM (NON-STERILE) (1)

122 TRANYLCYPROMINE SULFATE (1)

123 TRIFLUOPERAZINE HYDROCHLORIDE (1)

124 UMECLIDINIUM BROMIDE (1)

125 VILANTEROL TRIFENATATE (GW642444) (1)

126 VITAMIN B 12(CYANOCOBALAMIN) (1)

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01 BEECHAM LABORATORIES (1)

02 BEECHAM LABORATORIES DIV BEECHAM INC (2)

03 BEECHAM PHARMACEUTICALS (4)

04 BEECHAM PHARMACEUTICALS PTE LTD (3)

05 BEECHAM PHARMACEUTICALS UK DIV (1)

06 BEECHAM SA (1)

07 BEECHAM-MASSENGILL PHARMS DIV BEECHAM INC (1)

08 GLAXO (1)

09 GLAXO GROUP LTD DBA GLAXOSMITHKLINE (1)

10 GLAXO GROUP RESEARCH LTD (2)

11 GLAXO LABORATORIES SA (2)

12 GLAXO OPERATIONS UK LTD (1)

13 GLAXO PHARMACEUTICALS LTD (2)

14 GLAXO WELLCOME INC (19)

15 GLAXOCHEM LTD (8)

16 GLAXOSMITHKLINE (8)

17 GLAXOSMITHKLINE LLC (17)

18 IAF BIOCHEM INTERNATIONAL INC (1)

19 SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORP (11)

20 SMITH KLINE AND FRENCH LABORATORIES (4)

21 SMITH KLINE CONSUMER PRODUCTS (1)

22 SMITHKLINE AND BECKMAN INC (8)

23 SMITHKLINE BEECHAM (2)

24 SMITHKLINE BEECHAM ANIMAL HEALTH (1)

25 SMITHKLINE BEECHAM CORP (1)

26 SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE (1)

27 SMITHKLINE BEECHAM PHARMACEUTICALS (31)

28 SMITHKLINE BEECHAM PHARMACEUTICALS CO (1)

29 STIEFEL LABORATORIES INC (3)

30 WINTHROP PHARMACEUTICALS DIV STERLING DRUG INC (7)

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01 U.S.A (2)

02 United Kingdom (144)

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01 Active (10)

02 Inactive (136)

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01 Blank (146)

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  • FDA
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SMITH KLINE & FRENCH ...
Inactive
532
N/A
1963-04-05
II
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BEECHAM PHARMACEUTICA...
Inactive
5887
N/A
1985-06-05
II
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BEECHAM-MASSENGILL PH...
Inactive
2246
N/A
1974-03-05
II
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BEECHAM PHARMACEUTICA...
Inactive
1520
N/A
1970-04-28
II
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SMITHKLINE BEECHAM
Inactive
12933
N/A
1998-03-31
II
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SMITHKLINE BEECHAM PH...
Inactive
6104
N/A
1985-11-20
II
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GLAXOSMITHKLINE LLC
Active
25189
N/A
2011-12-21
II
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GLAXOCHEM LTD
Inactive
5885
N/A
1985-06-14
II
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GLAXOSMITHKLINE LLC
Inactive
24471
N/A
2011-02-11
II
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SMITHKLINE BEECHAM
Inactive
13201
N/A
1998-04-30
II
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