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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Lusochimica Spa

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01 Acebutolol Hydrochloride (1)

02 Benidipine (1)

03 Benidipine Hydrochloride (1)

04 Betaxolol (1)

05 Carteolol (1)

06 Chlorpropamide (1)

07 Cinacalcet Hydrochloride (1)

08 Clevidipine (1)

09 Clonidine (1)

10 Diltiazem Hydrochloride (1)

11 Eletriptan Hydrobromide (1)

12 Ezetimibe (1)

13 Fenoterol Hydrobromide (1)

14 Formoterol Fumarate (2)

15 Glibenclamide (1)

16 Glipizide (1)

17 Indacaterol Maleate (1)

18 Ipratropium Bromide (1)

19 Isosorbide Dinitrate (1)

20 Isoxsuprine Hydrochloride (1)

21 Manidipine (1)

22 Metaproterenol Hemisulfate (1)

23 NAFTIFINE HCL (1)

24 Nicardipine Hydrochloride (2)

25 Nifedipine (1)

26 Nimodipine (1)

27 Nisoldipine (1)

28 Nitrendipine (1)

29 Novasmasol (1)

30 Olodaterol Hydrochloride (1)

31 Oxymetazoline Hydrochloride (1)

32 Pindolol (1)

33 Propranolol Hydrochloride (1)

34 Ritodrine Hydrochloride (1)

35 Roflumilast (1)

36 Rotigotine (1)

37 Salbutamol Sulphate (1)

38 Salmeterol Xinafoate (1)

39 Silver Sulfadiazine (1)

40 Solifenacin Succinate (1)

41 Sulfadiazine Silver (1)

42 Terbutaline Sulphate (1)

43 Tiotropium Bromide (1)

44 Tolnaftate (1)

45 Trifluridine (1)

46 Xylometazoline Hydrochloride (1)

47 Blank (1)

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01 Active (13)

02 Inactive (13)

03 Blank (23)

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01 Valid (6)

02 Withdrawn by Holder (1)

03 Blank (42)

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01 217MF11180 (1)

02 218MF10961 (1)

03 221MF10085 (1)

04 227MF10092 (1)

05 229MF10205 (1)

06 Blank (44)

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01 Blank (49)

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USDMF

Found USDMF

12509
Active
CARTEOLOL HYDROCHLORIDE
1997-05-15
CEP/COS

Found CEP/COS

R1-CEP 2005-199 - Rev 01
Valid
Carteolol hydrochloride
2022-10-10
Japanese DMF

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Written Confirmation

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Application Number
12509
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
CARTEOLOL HYDROCHLORIDE
Carteolol hydrochloride
Issue/Submission Date
1997-05-15
2022-10-10
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USDMF

Found USDMF

23848
Active
FORMOTEROL FUMARATE DIHYDRATE
2010-05-10
CEP/COS

Found CEP/COS

CEP 2011-262 - Rev 02
Valid
Formoterol fumarate dihydrate, FRM
2023-09-05
Japanese DMF

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Written Confirmation

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Application Number
23848
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
FORMOTEROL FUMARATE DIHYDRATE
Formoterol fumarate dihydrate, FRM
Issue/Submission Date
2010-05-10
2023-09-05
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USDMF

Found USDMF

9430
Active
GLIBENCLAMIDE (GLYBURIDE)
1991-12-03
CEP/COS

Found CEP/COS

R1-CEP 2005-195 - Rev 00
Valid
Glibenclamide
2014-05-22
Japanese DMF

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Written Confirmation

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Application Number
9430
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
GLIBENCLAMIDE (GLYBURIDE)
Glibenclamide
Issue/Submission Date
1991-12-03
2014-05-22
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USDMF

Found USDMF

8979
Active
IPRATROPIUM BROMIDE
1991-02-15
CEP/COS

Found CEP/COS

R1-CEP 2004-220 - Rev 01
Valid
Ipratropium bromide
2020-11-26
Japanese DMF

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Written Confirmation

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Application Number
8979
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
IPRATROPIUM BROMIDE
Ipratropium bromide
Issue/Submission Date
1991-02-15
2020-11-26
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USDMF

Found USDMF

14979
Active
NIMODIPINE
2000-07-26
CEP/COS

Found CEP/COS

CEP 2022-403 - Rev 00
Valid
Nimodipine
2024-01-24
Japanese DMF

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Written Confirmation

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Application Number
14979
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
NIMODIPINE
Nimodipine
Issue/Submission Date
2000-07-26
2024-01-24
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USDMF

Found USDMF

28997
Active
ALBUTEROL SULFATE
2015-03-10
CEP/COS

Found CEP/COS

R1-CEP 2005-235 - Rev 02
Valid
Salbutamol sulfate
2023-04-03
Japanese DMF

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Written Confirmation

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Application Number
28997
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ALBUTEROL SULFATE
Salbutamol sulfate
Issue/Submission Date
2015-03-10
2023-04-03
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USDMF

Caution USDMF

10315
Inactive
RITODRINE HYDROCHLORIDE
1993-06-16
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

217MF11180
Ritodrine hydrochloride at Via Giot...
2005-12-12
Written Confirmation

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Application Number
10315
217MF11180
Status
Inactive
Fees Paid
N/A
 
Filing Details
RITODRINE HYDROCHLORIDE
Ritodrine hydrochloride at Via Giot...
Issue/Submission Date
1993-06-16
2005-12-12
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USDMF

Close USDMF

CEP/COS

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Japanese DMF

Found JDMF

227MF10092
Benidipine HCl at Via Libornese, 89...
2015-03-12
Written Confirmation

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Application Number
227MF10092
Status
 
Filing Details
Benidipine HCl at Via Libornese, 89...
Issue/Submission Date
2015-03-12
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USDMF

Found USDMF

10727
Active
BETAXOLOL HYDROCHLORIDE
1994-02-04
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
10727
Status
Active
Fees Paid
N/A
 
Filing Details
BETAXOLOL HYDROCHLORIDE
Issue/Submission Date
1994-02-04
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USDMF

Close USDMF

CEP/COS

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Japanese DMF

Found JDMF

221MF10085
Chlorpropamide at Via Libornese, 89...
2009-04-30
Written Confirmation

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Application Number
221MF10085
Status
 
Filing Details
Chlorpropamide at Via Libornese, 89...
Issue/Submission Date
2009-04-30
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