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

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01 AVINZA((R) (MORPHINE SULFATE EXTENDED-RELEASE CAPSULES) 30MG, 45MG, 60MG, 75MG, 90MG AND 120MG (1)

02 ELN-CT-105G (1)

03 ELND-005 (1)

04 FLUVOXAMINE MALEATE CR CAPSULES (1)

05 MELOXICAM NANOCRYSTAL® TABLETS (1)

06 MICROSPHERE DILUENT (1)

07 N1679 NANOCRYSTAL CAPSULE (1)

08 N1714 TABLETS (1)

09 N1752 EXTENDED RELEASE TABLETS, 18MG (1)

10 NCD MELOXICAM BULK INTERMEDIATE (1)

11 POLYMILL ® POLYSTYRENE MILLING MEDIA (1)

12 PROLEASE DILUENT USED FOR SUSPENSION OF PROLEASE MICROSPHERE PRODUCTS FOR PRODUCT ADMINISTRATION (1)

13 RAPAMYCIN NANOCRYSTAL COLLOIDAL DISPERSION-MEDIA MILLING PROCESS (1)

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01 ALKERMES GAINESVILLE LLC (3)

02 ALKERMES INC (10)

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01 Ireland (13)

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01 Active (4)

02 Inactive (9)

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01 Blank (13)

URL Supplier Web Content
ALKERMES INC
Inactive
16433
N/A
2003-02-21
II
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ALKERMES INC
Inactive
22903
N/A
2009-06-23
II
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ALKERMES INC
Inactive
13957
N/A
1999-01-22
II
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ALKERMES INC
Inactive
18805
N/A
2005-09-26
II
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ALKERMES INC
Active
22739
N/A
2009-05-05
II
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ALKERMES INC
Active
29935
N/A
2015-12-07
II
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ALKERMES INC
Active
29273
N/A
2015-07-15
II
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ALKERMES INC
Active
12571
N/A
1997-07-09
II
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ELND-005

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ALKERMES GAINESVILLE ...
Inactive
20561
N/A
2007-06-25
II
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N1679 NANOCRYSTAL CAPSULE

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ALKERMES GAINESVILLE ...
Inactive
22755
N/A
2009-05-01
II
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