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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Mallinckrodt Plc

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01 Acetoxyacetyl Chloride (2)

02 Aciclovir (2)

03 Amphetamine (7)

04 Amphetamine Aspartate (1)

05 Benzphetamine (1)

06 Buprenorphine (1)

07 Buprenorphine Hydrochloride (2)

08 Butalbital (1)

09 Calcitonin (1)

10 Calcium Stearate API (1)

11 Chlorpheniramine (1)

12 Chlorzoxazone (1)

13 Cocaine Hydrochloride (1)

14 Codeine Phosphate (2)

15 Codeine Sulfate (2)

16 Corticotropin (1)

17 Desmopressin Acetate (1)

18 Dexchloropheniramine Maleate (1)

19 Dexmethylphenidate (1)

20 Dextroamphetamine Saccharate (1)

21 Dextropropoxyphene (2)

22 Dihydrocodeine Tartrate (2)

23 Dioctyl Sulfosuccinic Acid (1)

24 Diphenoxylate Hydrochloride (1)

25 Disodium Hydrogen Phosphate (2)

26 Docusate Sodium (1)

27 Doxylamine Succinate (1)

28 Exenatide (1)

29 Exenatide Synthetic (1)

30 Fentanyl (2)

31 Fentanyl Citrate (2)

32 Fentanyl Hydrochloride (1)

33 Ferrous Fumarate (1)

34 Gadoversetamide (1)

35 Gallium Chloride (2)

36 Hydrocodone Bitartrate (6)

37 Hydromorphone Hydrochloride (4)

38 Ibuprofen (4)

39 Indium (2)

40 Indium Trichloride (2)

41 Iotalamic Acid (2)

42 Ioversol (2)

43 Isosorbide Dinitrate (1)

44 Lenperone (1)

45 Leuprolide Acetate (2)

46 Levorphanol Tartrate (4)

47 Lisdexamfetamine Dimesylate (2)

48 Magnesium (1)

49 Methadone (1)

50 Methadone Hydrochloride (4)

51 Methylnaltrexone Bromide (3)

52 Methylphenidate (1)

53 Methylphenidate Hydrochloride (2)

54 Morphine Sulfate (3)

55 Nalbuphine (3)

56 Nalmefene Hydrochloride (2)

57 Naloxone Hydrochloride (1)

58 Naltrexone (1)

59 Naltrexone Hydrochloride (2)

60 Natriuretic Peptide, Brain (1)

61 Noscapine (3)

62 Octreoscan (2)

63 Opium (1)

64 Oxycodone Hydrochloride (3)

65 Oxycodone Terephthalate (2)

66 Oxymorphone (1)

67 Oxymorphone Hydrochloride (3)

68 Paracetamol (11)

69 Pemoline (1)

70 Pentazocine (1)

71 Pentetic Acid (1)

72 Perflutren (1)

73 Pethidine Hydrochloride (2)

74 Potassium Chloride (1)

75 Potassium Iodide (1)

76 Potassium Nitrate (1)

77 Pramlintide (1)

78 Propoxyphene Napsylate (2)

79 Pseudoephedrine (1)

80 Pseudoephedrine Hydrochloride (1)

81 Reserpine (1)

82 Selenomethionine (1)

83 Silicon Dioxide API (2)

84 Silver Sulfadiazine (1)

85 Sodium Bitartrate (1)

86 Sodium Dihydrogen Phosphate Monohydrate (2)

87 Sodium Fluoride (1)

88 Sodium Iodide (1)

89 Sodium Molybdate (1)

90 Sodium Perrhenate (1)

91 Sodium Sulfate (1)

92 Strontium Nitrate (1)

93 Sufentanil Citrate (4)

94 Tetrahydrocannabinol (1)

95 Thallium Chloride (2)

96 Theophylline (3)

97 Tolmetin Sodium (2)

98 Ziconotide (1)

99 Zomepirac (1)

100 Blank (25)

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01 Active (75)

02 Inactive (119)

03 Blank (8)

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01 Expired (1)

02 Valid (17)

03 Withdrawn by Holder (1)

04 Blank (183)

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01 218MF10580 (1)

02 218MF10631 (1)

03 218MF10904 (1)

04 218MF10905 (1)

05 221MF10169 (1)

06 221MF10283 (1)

07 223MF10179 (1)

08 226MF10059 (1)

09 229MF10161 (1)

10 Blank (193)

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01 Blank (202)

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USDMF

Found USDMF

4203
Active
COMPAP™
1981-06-12
CEP/COS

Found CEP/COS

R1-CEP 1996-039 - Rev 04
Valid
Paracetamol
2018-04-25
Japanese DMF

Found JDMF

218MF10905
Acetaminophen at 385 Marshall Ave, ...
2006-11-10
Written Confirmation

Close WC

Application Number
4203
218MF10905
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
COMPAP™
Paracetamol
Acetaminophen at 385 Marshall Ave, ...
Issue/Submission Date
1981-06-12
2018-04-25
2006-11-10
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USDMF

Caution USDMF

8074
Inactive
FENTANYL ALKALOID
1989-05-11
CEP/COS

Found CEP/COS

CEP 2005-260 - Rev 03
Valid
Fentanyl
2024-02-14
Japanese DMF

Found JDMF

221MF10283
Fentanyl at 385 Marshall Ave, Webst...
2009-12-22
Written Confirmation

Close WC

Application Number
8074
221MF10283
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
FENTANYL ALKALOID
Fentanyl
Fentanyl at 385 Marshall Ave, Webst...
Issue/Submission Date
1989-05-11
2024-02-14
2009-12-22
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USDMF

Caution USDMF

7051
Inactive
FENTANYL CITRATE USP
1987-07-02
CEP/COS

Found CEP/COS

CEP 2009-097 - Rev 02
Valid
Fentanyl citrate
2024-01-30
Japanese DMF

Found JDMF

229MF10161
Fentanyl citrate FP at 385 Marshall...
2017-08-17
Written Confirmation

Close WC

Application Number
7051
229MF10161
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
FENTANYL CITRATE USP
Fentanyl citrate
Fentanyl citrate FP at 385 Marshall...
Issue/Submission Date
1987-07-02
2024-01-30
2017-08-17
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USDMF

Found USDMF

15385
Active
DEXTROAMPHETAMINE SULFATE USP
2001-04-18
CEP/COS

Found CEP/COS

R0-CEP 2020-076 - Rev 00
Valid
Dexamfetamine sulfate
2021-07-26
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
15385
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
DEXTROAMPHETAMINE SULFATE USP
Dexamfetamine sulfate
Issue/Submission Date
2001-04-18
2021-07-26
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USDMF

Found USDMF

24928
Active
BUPRENORPHINE BASE EP, CODE 3205
2012-05-02
CEP/COS

Found CEP/COS

R1-CEP 2013-098 - Rev 00
Valid
Buprenorphine
2021-06-24
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
24928
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
BUPRENORPHINE BASE EP, CODE 3205
Buprenorphine
Issue/Submission Date
2012-05-02
2021-06-24
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USDMF

Found USDMF

24927
Active
BUPRENORPHINE HYDROCHLORIDE USP, CO...
2012-05-02
CEP/COS

Found CEP/COS

R1-CEP 2013-048 - Rev 00
Valid
Buprenorphine hydrochloride
2021-05-04
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
24927
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
BUPRENORPHINE HYDROCHLORIDE USP, CO...
Buprenorphine hydrochloride
Issue/Submission Date
2012-05-02
2021-05-04
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USDMF

Found USDMF

26366
Active
NORBUPRENORPHINE HYDROCHLORIDE
2012-11-27
CEP/COS

Found CEP/COS

R0-CEP 2023-107 - Rev 00
Valid
Buprenorphine hydrochloride, Proces...
2023-08-24
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
26366
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
NORBUPRENORPHINE HYDROCHLORIDE
Buprenorphine hydrochloride, Proces...
Issue/Submission Date
2012-11-27
2023-08-24
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USDMF

Found USDMF

4839
Active
CODEINE PHOSPHATE
1983-03-11
CEP/COS

Found CEP/COS

R1-CEP 1999-152 - Rev 04
Valid
Codeine phosphate hemihydrate
2018-10-04
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
4839
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CODEINE PHOSPHATE
Codeine phosphate hemihydrate
Issue/Submission Date
1983-03-11
2018-10-04
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USDMF

Found USDMF

10128
Active
FENTANYL CITRATE (NEW PROCESS)
1993-03-15
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

218MF10580
Fentanyl citrate at 385 Marshall Av...
2006-06-22
Written Confirmation

Close WC

Application Number
10128
218MF10580
Status
Active
Fees Paid
Reviewed
 
Filing Details
FENTANYL CITRATE (NEW PROCESS)
Fentanyl citrate at 385 Marshall Av...
Issue/Submission Date
1993-03-15
2006-06-22
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USDMF

Found USDMF

6972
Active
IOVERSOL
1987-05-13
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

226MF10059
Ioversol at Damastown, Mulhuddart, ...
2014-03-06
Written Confirmation

Close WC

Application Number
6972
226MF10059
Status
Active
Fees Paid
N/A
 
Filing Details
IOVERSOL
Ioversol at Damastown, Mulhuddart, ...
Issue/Submission Date
1987-05-13
2014-03-06
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