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

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

ELN-CT-105G

ELND-005

FLUVOXAMINE MALEATE CR CAPSULES

MELOXICAM NANOCRYSTAL® TABLETS

MICROSPHERE DILUENT

Medisorb 5050 DL 4AP

N1679 NANOCRYSTAL CAPSULE

N1714 TABLETS

N1752 EXTENDED RELEASE TABLETS, 18MG

NCD MELOXICAM BULK INTERMEDIATE

POLYMILL ® POLYSTYRENE MILLING MEDIA

PROLEASE DILUENT USED FOR SUSPENSION OF PROLEASE MICROSPHERE PRODUCTS FOR PRODUCT ADMINISTRATION

RAPAMYCIN NANOCRYSTAL COLLOIDAL DISPERSION-MEDIA MILLING PROCESS

Theophylline sustained-release matrix

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Status - Active

Status - Inactive

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217MF10312

223MF20001

225MF10176

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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
MICROSPHERE DILUENT
Issue/Submission Date
2009-05-05
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
MICROSPHERE DILUENT
Issue/Submission Date
2009-05-05
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
FLUVOXAMINE MALEATE CR CAPSULES
Issue/Submission Date
1999-01-22
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
FLUVOXAMINE MALEATE CR CAPSULES
Issue/Submission Date
1999-01-22
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
MELOXICAM NANOCRYSTAL® TABLETS
Issue/Submission Date
2005-09-26
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
MELOXICAM NANOCRYSTAL® TABLETS
Issue/Submission Date
2005-09-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
NCD MELOXICAM BULK INTERMEDIATE
Issue/Submission Date
2015-12-07
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
NCD MELOXICAM BULK INTERMEDIATE
Issue/Submission Date
2015-12-07
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
AVINZA((R) (MORPHINE SULFATE EXTEND...
Issue/Submission Date
2003-02-21
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
AVINZA((R) (MORPHINE SULFATE EXTEND...
Issue/Submission Date
2003-02-21
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
POLYMILL ® POLYSTYRENE MILLING MED...
Issue/Submission Date
2015-07-15
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
POLYMILL ® POLYSTYRENE MILLING MED...
Issue/Submission Date
2015-07-15
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
RAPAMYCIN NANOCRYSTAL COLLOIDAL DIS...
Issue/Submission Date
1997-07-09
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Rapamycin NanoCrystal Colloidal Dis...
Issue/Submission Date
2013-09-18
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
RAPAMYCIN NANOCRYSTAL COLLOIDAL DIS...
Rapamycin NanoCrystal Colloidal Dis...
Issue/Submission Date
1997-07-09
2013-09-18
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Theophylline sustained-release matr...
Issue/Submission Date
2005-07-12
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Theophylline sustained-release matr...
Issue/Submission Date
2005-07-12
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ELN-CT-105G
Issue/Submission Date
2009-06-23
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ELN-CT-105G
Issue/Submission Date
2009-06-23
Supporting Info

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
PROLEASE DILUENT USED FOR SUSPENSIO...
Issue/Submission Date
1999-03-18
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
PROLEASE DILUENT USED FOR SUSPENSIO...
Issue/Submission Date
1999-03-18
Supporting Info

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ELND-005
Issue/Submission Date
2007-06-25
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
ELND-005
Issue/Submission Date
2007-06-25
Supporting Info

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
N1679 NANOCRYSTAL CAPSULE
Issue/Submission Date
2009-05-01
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
N1679 NANOCRYSTAL CAPSULE
Issue/Submission Date
2009-05-01
Supporting Info

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
N1714 TABLETS
Issue/Submission Date
2011-02-14
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
N1714 TABLETS
Issue/Submission Date
2011-02-14
Supporting Info

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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
N1752 EXTENDED RELEASE TABLETS, 18M...
Issue/Submission Date
2012-08-28
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
N1752 EXTENDED RELEASE TABLETS, 18M...
Issue/Submission Date
2012-08-28
Supporting Info

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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info

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