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

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01 COMPACTIN (1)

02 ERYTHROMYCIN BASE (1)

03 ERYTHROMYCIN BASE DIHYDRATE (1)

04 ERYTHROMYCIN ESTOLATE (1)

05 ERYTHROMYCIN ETHYLSUCCINATE (1)

06 ERYTHROMYCIN STEARATE (1)

07 FAMOTIDINE (1)

08 FOSFOMYCIN PHENYLAMMONIUM SALT (1)

09 FOSFOMYCIN SODIUM (1)

10 FOSFOMYCIN TROMETHAMINE (1)

11 FUSIDIC ACID (1)

12 LOVASTATIN (1)

13 LOVASTATIN (TECHNICAL GRADE) (1)

14 SODIUM FUSIDATE (1)

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01 ERCROS INDUSTRIAL SA FYSE (3)

02 ERCROS SA (11)

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01 Spain (14)

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01 Active (9)

02 Inactive (5)

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01 Complete (4)

02 Blank (10)

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ERCROS INDUSTRIAL SA ...
Inactive
19411
N/A
2006-04-26
II
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ERCROS SA
Active
13466
Complete
2013-10-24
2013-05-23
1998-09-01
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ERCROS SA
Active
37397
Complete
2023-02-15
2023-01-18
2022-09-14
II
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ERCROS SA
Inactive
13468
N/A
1998-09-01
II
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ERCROS SA
Active
13654
Complete
2017-08-01
2017-07-13
1998-09-01
II
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ERCROS INDUSTRIAL SA ...
Inactive
13467
N/A
1998-09-01
II
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ERCROS SA
Active
13086
N/A
1998-07-21
II
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ERCROS SA
Active
11582
N/A
1995-07-10
II
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ERCROS SA
Active
14341
N/A
1999-08-04
II
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ERCROS SA
Active
31195
Complete
2017-06-20
2016-12-22
2017-02-24
II
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