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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Signa S.a. De C.v.

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01 Abacavir Sulfate (1)

02 Aciclovir (1)

03 Alendronate Sodium (1)

04 Allopurinol (1)

05 Asenapine Maleate (1)

06 Atazanavir Sulfate (1)

07 Atorvastatin (1)

08 Balsalazide Disodium (1)

09 Brexpiprazole (1)

10 Capecitabine (1)

11 Clopidogrel (1)

12 Didanosine (1)

13 Divalproex Sodium (1)

14 Duloxetine (1)

15 Entacapone (1)

16 Ezetimibe (1)

17 Famciclovir (1)

18 Fluconazole (1)

19 Gatifloxacin (1)

20 Gemfibrozil (2)

21 Imatinib Mesylate (1)

22 Irbesartan (1)

23 Lacosamide (1)

24 Lamivudine (1)

25 Lanthanum Carbonate (1)

26 Levetiracetam (1)

27 Mesalazine (1)

28 Methyldopa (1)

29 Metronidazole (1)

30 Nadolol (1)

31 Nefazodone Hydrochloride (1)

32 Oxcarbazepine (1)

33 Paroxetine Hydrochloride (1)

34 Pazopanib Hydrochloride (1)

35 Pioglitazone Hydrochloride (1)

36 Pirfenidone (1)

37 Ponatinib (1)

38 Progesterone (1)

39 Quinapril (1)

40 Sildenafil Citrate (1)

41 Sitagliptin Phosphate (1)

42 Sodium Valproate (1)

43 Telmisartan (1)

44 Terazosin HCl (1)

45 Tiagabine Hydrochloride (1)

46 Topiramate (1)

47 Valsartan (1)

48 Zidovudine (1)

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01 Active (19)

02 Inactive (29)

03 Blank (1)

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01 Expired (3)

02 Valid (1)

03 Withdrawn by Holder (1)

04 Blank (44)

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01 220MF10130 (1)

02 Blank (48)

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01 Blank (49)

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USDMF

Found USDMF

15841
Active
ALLOPURINOL USP
2002-02-04
CEP/COS

Found CEP/COS

R1-CEP 2001-335 - Rev 03
Valid
Allopurinol
2021-03-05
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
15841
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
ALLOPURINOL USP
Allopurinol
Issue/Submission Date
2002-02-04
2021-03-05
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USDMF

Found USDMF

15168
Active
PIRFENIDONE EP
2000-11-30
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

220MF10130
Pirfenidone at Av. Industria Automo...
2008-05-20
Written Confirmation

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Application Number
15168
220MF10130
Status
Active
Fees Paid
Reviewed
 
Filing Details
PIRFENIDONE EP
Pirfenidone at Av. Industria Automo...
Issue/Submission Date
2000-11-30
2008-05-20
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USDMF

Found USDMF

23644
Active
ABACAVIR SULFATE USP
2010-03-19
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
23644
Status
Active
Fees Paid
Reviewed
 
Filing Details
ABACAVIR SULFATE USP
Issue/Submission Date
2010-03-19
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USDMF

Found USDMF

22949
Active
ACYCLOVIR USP
2009-07-16
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
22949
Status
Active
Fees Paid
Reviewed
 
Filing Details
ACYCLOVIR USP
Issue/Submission Date
2009-07-16
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USDMF

Found USDMF

21574
Active
ATORVASTATIN CALCIUM PROPYLENE GLYC...
2008-04-29
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
21574
Status
Active
Fees Paid
Reviewed
 
Filing Details
ATORVASTATIN CALCIUM PROPYLENE GLYC...
Issue/Submission Date
2008-04-29
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USDMF

Found USDMF

18894
Active
BALSALAZIDE DISODIUM DIHYDRATE USP
2005-10-21
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
18894
Status
Active
Fees Paid
Reviewed
 
Filing Details
BALSALAZIDE DISODIUM DIHYDRATE USP
Issue/Submission Date
2005-10-21
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USDMF

Found USDMF

33560
Active
BREXPIPRAZOLE
2019-03-11
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
33560
Status
Active
Fees Paid
Reviewed
 
Filing Details
BREXPIPRAZOLE
Issue/Submission Date
2019-03-11
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USDMF

Found USDMF

15721
Active
CLOPIDOGREL BISULPHATE USP
2001-11-13
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
15721
Status
Active
Fees Paid
N/A
 
Filing Details
CLOPIDOGREL BISULPHATE USP
Issue/Submission Date
2001-11-13
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USDMF

Found USDMF

21833
Active
DULOXETINE HYDROCHLORIDE USP
2008-07-30
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
21833
Status
Active
Fees Paid
Reviewed
 
Filing Details
DULOXETINE HYDROCHLORIDE USP
Issue/Submission Date
2008-07-30
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USDMF

Found USDMF

22713
Active
FAMCICLOVIR USP
2009-04-09
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
22713
Status
Active
Fees Paid
N/A
 
Filing Details
FAMCICLOVIR USP
Issue/Submission Date
2009-04-09
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