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

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01 AMANTADINE HYDROCHLORIDE (1)

02 ANAGRELIDE HYDROCHLORIDE (1)

03 ATENOLOL (1)

04 CARTEOLOL HYDROCHLORIDE (1)

05 DICLOFENAC HYDROXY ETHYL PYRROLIDINE (1)

06 ETODOLAC (1)

07 FENOFIBRATE (1)

08 FLECAINIDE ACETATE (1)

09 GLIPIZIDE (1)

10 GLYCOPYRROLATE (1)

11 LURASIDONE HYDROCHLORIDE (1)

12 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN MILANO, ITALY. (1)

13 MELOXICAM (1)

14 MEMANTINE HYDROCHLORIDE (1)

15 PHENYLBUTAZONE (1)

16 TOLMETIN SODIUM (1)

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01 AMSA ANONIMA MATERIE SINTETICHE AND AFFINI SPA (3)

02 AMSA ANONIMA MEDICINALI SINTETICI AND AFFINI SPA (3)

03 AMSA SPA (7)

04 ANONIMA MATERIE SINTETICHE AND AFFINI (AMSA) SPA (3)

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01 Italy (16)

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01 Active (9)

02 Inactive (7)

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01 Complete (5)

02 Blank (11)

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ANONIMA MATERIE SINTE...
Active
29486
N/A
2015-09-01
II
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AMSA ANONIMA MATERIE ...
Inactive
16969
N/A
2003-11-12
II
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AMSA ANONIMA MEDICINA...
Inactive
7265
N/A
1987-12-23
II
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AMSA SPA
Inactive
14946
N/A
2000-07-03
II
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AMSA SPA
Active
14831
N/A
2000-04-10
II
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AMSA SPA
Active
11359
N/A
1995-02-20
II
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ANONIMA MATERIE SINTE...
Inactive
16971
N/A
2003-11-17
II
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AMSA ANONIMA MATERIE ...
Active
14749
N/A
2000-02-29
II
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AMSA SPA
Active
13101
Complete
2014-03-21
2013-09-23
1998-07-30
II
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AMSA SPA
Active
16972
Complete
2015-03-13
2015-03-06
2003-11-13
II
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