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

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01 6-BETA-NALTREXOL HYDROCHLORIDE (1)

02 ABX AND CBX BONDED PHASE SILICA GELS (1)

03 ACCURBRON, S.R. (CONTROLLED RELEASE THEOPHYLLINE) (1)

04 ACETAMINOPHEN (1)

05 ACETAMINOPHEN CONTROLLED-RELEASE BEADS 325 MG. (1)

06 ACETAMINOPHEN USP (1)

07 ACETOXYACETYL CHLORIDE (2)

08 ACTIFED S.A. BRAND OF PSEUDOEPHEDRINE HCL 120MG & TRIPTOLIDINE 5MG (1)

09 ACYCLOVIR USP (MICRONIZED), CODED 2524 (1)

10 ACYCLOVIR, USP (1)

11 AEROLATE CONTROLLED-RELEASE CAPSULES CONTAINING THEOPHYLLINE (1)

12 AMPHETAMINE ASPARTATE (1)

13 AMPHETAMINE BASE CODE 6507 (1)

14 AMPHETAMINE SULFATE (1)

15 BENZPHETAMINE HYDROCHLORIDE, CODE 9223 (1)

16 BIOLOGICAL INDICATOR PROGRAM APPLIED MARYLAND HEIGHTS, MO PLANT SITE (1)

17 BRAIN NATRIURETIC PEPTIDE (1)

18 BUPRENORPHINE BASE EP, CODE 3205 (1)

19 BUPRENORPHINE HYDROCHLORIDE USP, CODE 3210 (1)

20 BUTALBITAL USP, CODE 5678 (1)

21 CALCITONIN, SALMON (1)

22 CHLORPHENIRAMINE POLISTIREX (1)

23 CHLORPHENIRAMINE POLISTIREX FOR SUSPENSION, CODE 7480 (1)

24 CHLORZOXAZONE (1)

25 COCAINE HYDROCHLORIDE USP (1)

26 CODACET-60 (TM) (1)

27 CODEINE PHOSPHATE (1)

28 CODEINE SULFATE (1)

29 CODEINE SULFATE USP POWDER (1)

30 COMPAP (TM) (1)

31 COMPAP 90 (ACETAMINOPHEN USP 90% ANHYDROUS BASIS) (1)

32 COMPAP SDCRSL (1)

33 COMPAP WSE, CODE 2907 (1)

34 COMPAP™ (1)

35 COMPAP™ COURSE L (1)

36 CT50034 (1)

37 CYCLOTRON FACILITY-MARYLAND HEIGHTS, MO. (1)

38 Compap™ L (Acetaminophen USP 90% Anhydrous Basis) (1)

39 D-PROPOXYPHENE NAPSYLATE USP CRYSTALS (1)

40 D-PSEUDOEPHEDRINE FOR TIME RELEASE BEAD (1)

41 DCI-90 (1)

42 DCI™-63 (IBUPROFEN USP 63%) (1)

43 DESMOPRESSIN (1)

44 DEXMETHYLPHENIDATE HYDROCHLORIDE (1)

45 DEXTROAMPHETAMINE BASE (1)

46 DEXTROAMPHETAMINE SACCHARATE (1)

47 DEXTROAMPHETAMINE SULFATE USP (1)

48 DEXTROCET-N2000 (1)

49 DEXTROMETHADONE HYDROCHLORIDE (1)

50 DIETHYLENETRIAMINEPENTAACETIC ACID (DTPA) (1)

51 DIOCTYL SODIUM SULFOSUCCINATE IN P E G (1)

52 DIOCYTL SODIUM SULFOSUCCINATE IN POLYETHYLENE GLYSOL 400 (1)

53 DIPHENOXYLATE HYDROCHLORIDE USP (1)

54 DOXYLAMINE SUCCINATE USP AS PRODUCED IN THE ST. LOUIS MO PLANT (1)

55 DRONABINOL IN SESAME OIL (1)

56 EXENATIDE (1)

57 EXENDIN-4 (1)

58 FACILITIES, PERSONNEL,AND G.O.P. FOR THE ST. LOUIS, MISSOURI PLANT (1)

59 FACILITIES, PROCEDURES AND PERSONNEL (1)

60 FACILITIES-PERSONNEL-GEN. OPERATING PROCEDURES RALEIGH NC CHEM. PLANT (1)

61 FACILS & PERSONNEL FOR THE RAD PHARM INC CYCLOTRIN ON MAHLER RD. CA. (1)

62 FENTANYL ALKALOID (2)

63 FENTANYL CITRATE (NEW PROCESS) (1)

64 FENTANYL CITRATE USP (1)

65 FENTANYL HYDROCHLORIDE (1)

66 FERROUS FUMARATE "TOLERON" (1)

67 GALLIUM CHLORIDE (GA-67) (1)

68 GALLIUM CHLORIDE GA-67 (1)

69 GASTROMARK (FERUMOXSIL) BOWEL MARKER (1)

70 H.P. ACTHAR GEL (REPOSITORY CORTICOTROPIN INJECTION) (1)

71 HEXABRIX X-RAY CONTRAST MEDIA (1)

72 HYDROCODONE ALKALOID (1)

73 HYDROCODONE BASE (NP) (1)

74 HYDROCODONE BITARTRATE USP CRYSTALS (1)

75 HYDROCODONE BITARTRATE USP CRYSTALS (NP) (1)

76 HYDROCODONE POLISTIREX (1)

77 HYDROCODONE POLISTIREX FOR SUSPENSION, CODE 7490 (1)

78 HYDROMORPHONE BASE (1)

79 HYDROMORPHONE HYDROCHLORIDE (1)

80 HYDROMORPHONE HYDROCHLORIDE USP (NP) (1)

81 IBUPROFEN DCI-63 (1)

82 IBUPROFEN S (+) TABLETS (1)

83 IBUPROFEN TIMED-RELEASE 600 MG. TALBETS (1)

84 INDIUM CHL IN 111 RADIOCHEM. SOL. AS PRODUCED IN BURLINGAME CA. FACILS (1)

85 INDIUM CHLORIDE IN-111 (1)

86 INDIUM IN-111 CHLORIDE STERILE SOLUTION (1)

87 INVESTIGATIONAL DRUGS (1)

88 IOTHALAMIC ACID USP (2)

89 IOVERSOL (1)

90 IOVERSOL, DRUG SUBSTANCE FOR OPTIRAY (1)

91 ISORBIDE DINITRATE C.R. CAPS 80MG (1)

92 LENPERONE 4'-FLUORO-4-[4-(p-FLUORO-BENZOYL)-PIPERDINO] BUTYROPHENONE (1)

93 LEUPROLIDE ACETATE (1)

94 LEUPROLIDE ACETATE (SPECIAL) (1)

95 LEVOAMPHETAMINE SULFATE CODE 8890 (1)

96 LEVORPHANOL BASE (1)

97 LEVORPHANOL TARTRATE (2)

98 LEVORPHANOL TARTRATE USP SPECIAL (1)

99 LISDEXAETAMINE DIMESYLATE (2)

100 MANUFACTURING & CONTROLS FOR LEVO ALPHA METHADYL ACETATE HYDROCHLORIDE (1)

101 MANUFACTURING FACILITY AT RALEIGH, NORTH CAROLINA (1)

102 MANUFACTURING SITE, FACILITIES, PERSONNEL AND GENERAL OPERATING PROCEDURES IN PETTEN, HOLLAND FACILITY. (1)

103 MEPERIDINE HYDROCHLORIDE INJECTION USP 10MG/ML (1)

104 MEPERIDINE HYDROCHLORIDE, USP (1)

105 MERCURY 195M/GOLD 195M GENERATORS-FACILS,METHDS,CONTRL FOR PREPARATION (1)

106 METHADONE BASE SPECIAL (1)

107 METHADONE HCL FLAVORED CONCENTRATE (1)

108 METHADONE HYDROCHLORIDE (1)

109 METHADONE HYDROCHLORIDE USP (1)

110 METHYLNALTREXONE BROMIDE, CODE 1251 (1)

111 METHYLPHENIDATE BASE (1)

112 METHYLPHENIDATE HYDROCHLORIDE USP (1)

113 METHYLPHENIDATE HYDROCHLORIDE USP (NP) (1)

114 MOLYDENUM 99:TECHNETIUM-99M (1)

115 MORPHINE ALKALOID, CODE 1547 (1)

116 MORPHINE SULFATE (1)

117 MORPHINE SULFATE INJECTION USP (1)

118 NALBUPHINE HYDROCHLORIDE (1P) (1)

119 NALBUPHINE HYDROCHLORIDE (LOW BETA EPIMER) CODE 3310 (1)

120 NALBUPHINE HYDROCHLORIDE CODE 3300 (1)

121 NALMEFENE BASE (1)

122 NALMEFENE HYDROCHLORIDE (1)

123 NALOXONE HCL USP DIHYDRATE (1)

124 NALTREXONE BASE (1)

125 NALTREXONE HCL (1)

126 NALTREXONE METHOBROMIDE (2)

127 NORBUPRENORPHINE HYDROCHLORIDE (1)

128 NOSCAPINE USP SMALL CRYSTALS AND NOSCAPINE HYDROCHLORIDE PURIFIED (1)

129 NOSCAPINE USP SMALL CRYSTALS CODE 6040 AND NOSCAPINE HYDROCHLORIDE PURIFIED CODE 6150 (1)

130 NOSCAPINE USP/EP CRYSTALS CODE 6047 (1)

131 OCTREOSCAN REACTION VIAL (1)

132 OCTREOSCAN REACTION VIAL, PENETREOTIDE LYPHOLIZED (1)

133 OPIUM TINCTURE 2% (1)

134 OPTIMARK(R) (GADOVERSETAMIDE INJECTION) PARAMETRIC RELEASE (1)

135 OPTISON (1)

136 OXYCODONE BASE - CODE 8180 (1)

137 OXYCODONE HYDROCHLORIDE PURIFIED RECRYSTALLIZED (1)

138 OXYCODONE HYDROCHLORIDE USP (D) (1)

139 OXYCODONE TEREPHTHALATE (1)

140 OXYCODONE TEREPHTHALATE-D (1)

141 OXYMORPHONE BASE (1)

142 OXYMORPHONE HYDROCHLORIDE (1)

143 OXYMORPHONE HYDROCHLORIDE USP (1)

144 PARACETAMOL DC (PVP) 284N (1)

145 PARACETAMOL DC 272N (GELATIN) (1)

146 PARZONE BITARTRATE (DIHYDROCODEINE BITARTRATE) (1)

147 PEI BONDED PHASE SILICA GEL (1)

148 PEMOLINE MALLINCKRODT CODE 1500 (1)

149 PENTAZOCINE HYDROCHLORIDE USP (1)

150 POTASSIUM CHLORIDE (1)

151 POTASSIUM IODIDE USP GRANULAR FOOD GRADE, CODE 1112 AND POTASSIUM IODIDE BP IODURE DE POTASSIUM, CODE 1220 (1)

152 POTASSIUM NITRATE TAC (1)

153 PRAMLINTIDE STD AMYLIN (1)

154 PROCEDS & CONTRLS FOR PROCESSING OF INDIUM IN-111(CHL & CITRATE) (1)

155 PRODUCTION OF TALLOUS T1-201 CHL AT THE BURLINGAME, CA (1)

156 PROPOXYPHENE HYDROCHLORIDE (1)

157 PROPOXYPHENE HYDROCHLORIDE USP POWDER (E SUB) (1)

158 PROPOXYPHENE NAPSYLATE (1)

159 PROSAPTIDE (1)

160 PROSAPTIDE TX 14(A), CODE 8200 (1)

161 RESERPINE (1)

162 SELENOMETHIONINE (1)

163 SILVER SULFADIAZINE (1)

164 SOD. IODIDE I-123 RADIOCHEM. SOL.-BURLINGAME,CA-(D FORMERLY RADPHARM (1)

165 SODIUM FLUORIDE (1)

166 SODIUM HYDROGEN L-TARTRATE (1)

167 SODIUM IODIDE I-123 (1)

168 SODIUM MOLYBDATE (99MO) (1)

169 SODIUM PERRHENATE RE 186 INJECTION, MARYLAND HEIGHTS, MO (1)

170 SODIUM PHOSPHATE DIBASIC USP POWDER (DRIED) (1)

171 SODIUM PHOSPHATE MONOBASIC ANHYDRUS CODE 7869 (1)

172 SODIUM PHOSPHATE MONOBASIC USP MONOHYDRATE GRANULAR FOOD GRADE (1)

173 SODIUM PHOSPHATE, MONOBASIC MONOHYDRATE USP (1)

174 SODIUM SULFATE USP ANHYDROUS MILLED POWDER (1)

175 SOMOPHYLLIN CONTROLLED RELEASE THEOPHYLLINE 250MG (1)

176 STEAR-O-WET C (CALCIUM STEARATE) (1)

177 STRONTIUM NITRATE PURIFIED MNFG ST.LOUIS, MISSOURI FACILITIES (1)

178 SUFENTANIL BASE CODE 0310 (1)

179 SUFENTANIL BASE EP (1)

180 SUFENTANIL CITRATE USP (1)

181 SUFENTANIL CITRATE USP/EP (1)

182 THALLOUS CHLORIDE (T1-201) (1)

183 THALLOUS CHLORIDE TI 201 (1)

184 TOLMETIN SODIUM DIHYDRATE (1)

185 TOLMETIN SODIUM DIHYDRATE T.A. (1)

186 X-RAY CONTRAST MEDIA (1)

187 ZICONOTIDE (SNX-111), CODE 8068 (1)

188 ZOMEPIRAC (1)

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01 CURIUM US LLC (7)

02 DM GRAHAM LABORATORIES INC (9)

03 LIEBEL-FLARSHEIM CO LLC (1)

04 MALLINCKRODT BAKER INC (3)

05 MALLINCKRODT CANADA INC (2)

06 MALLINCKRODT CHEMICAL INC (20)

07 MALLINCKRODT CHEMICAL WORKS (1)

08 MALLINCKRODT INC (61)

09 MALLINCKRODT INC THE PHARMACEUTICALS BUSINESS OF COVIDIEN (6)

10 MALLINCKRODT LLC (2)

11 MALLINCKRODT MEDICAL INC (1)

12 MALLINCKRODT PHARMACEUTICALS DIV MALLINCKRODT INC (1)

13 MALLINCKRODT PHARMS DIV MALLINCKRODT INC (2)

14 MALLINCKRODT SPECIALTY CHEMICALS CO (4)

15 SPECGX LLC (74)

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01 U.S.A (194)

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01 Active (75)

02 Inactive (119)

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01 Complete (35)

02 Blank (159)

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MALLINCKRODT INC THE ...
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1989-01-30
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DM GRAHAM LABORATORIE...
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MALLINCKRODT SPECIALT...
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1985-01-21
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DM GRAHAM LABORATORIE...
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SPECGX LLC
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2012-11-27
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MALLINCKRODT INC
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1987-06-29
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MALLINCKRODT INC
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1987-06-29
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DM GRAHAM LABORATORIE...
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1982-04-15
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MALLINCKRODT CHEMICAL...
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