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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Olon S.p.A

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Olon S.p.A
Italy Flag
Country
Country
Italy
Address
Address
Societa con Socio unico, Strada Rivoltana km 6/7, 20090 Rodano (Milano)
Telephone
Telephone
+39 02 95 231
Twitter
Twitter

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ListList of Products
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USDMF

Found USDMF

20045
Active
QUETIAPINE FUMARATE
2006-12-15
CEP/COS

Found CEP/COS

R1-CEP 2015-022 - Rev 01
Valid
Quetiapine Fumarate
2023-06-16
Japanese DMF

Found JDMF

223MF10171
Quetiapine fumarate at Unit No. 3B-...
2011-12-22
Written Confirmation

Caution WC

Indian CDSCO WC-0197
Expired
Quetiapine Fumarate (IH)
2019-09-09
Application Number
20045
223MF10171
Indian CDSCO WC-0197
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-09-08
Filing Details
QUETIAPINE FUMARATE
Quetiapine Fumarate
Quetiapine fumarate at Unit No. 3B-...
Quetiapine Fumarate (IH)
Issue/Submission Date
2006-12-15
2023-06-16
2011-12-22
2019-09-09
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USDMF

Found USDMF

10685
Active
ACYCLOVIR
1994-01-12
CEP/COS

Found CEP/COS

R1-CEP 2003-218 - Rev 06
Valid
Aciclovir
2021-04-26
Japanese DMF

Found JDMF

218MF10016
Acyclovir at Strada Rivoltana, km 6...
2006-01-27
Written Confirmation

Close WC

Application Number
10685
218MF10016
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ACYCLOVIR
Aciclovir
Acyclovir at Strada Rivoltana, km 6...
Issue/Submission Date
1994-01-12
2021-04-26
2006-01-27
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USDMF

Found USDMF

20445
Active
ACYCLOVIR
2007-04-05
CEP/COS

Found CEP/COS

R1-CEP 2003-041 - Rev 05
Valid
Aciclovir
2020-10-20
Japanese DMF

Found JDMF

303MF10178
Aciclovir at Strada Rivoltana, km 6...
2021-12-15
Written Confirmation

Close WC

Application Number
20445
303MF10178
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
ACYCLOVIR
Aciclovir
Aciclovir at Strada Rivoltana, km 6...
Issue/Submission Date
2007-04-05
2020-10-20
2021-12-15
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USDMF

Found USDMF

19621
Active
ADAPALENE DRUG SUBSTANCE
2006-07-10
CEP/COS

Found CEP/COS

R0-CEP 2022-259 - Rev 00
Valid
Adapalene
2023-07-28
Japanese DMF

Found JDMF

228MF10145
Adapalene at Strada Rivoltana km. 6...
2016-08-03
Written Confirmation

Close WC

Application Number
19621
228MF10145
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ADAPALENE DRUG SUBSTANCE
Adapalene
Adapalene at Strada Rivoltana km. 6...
Issue/Submission Date
2006-07-10
2023-07-28
2016-08-03
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USDMF

Found USDMF

27497
Active
BEZAFIBRATE
2013-09-03
CEP/COS

Found CEP/COS

R1-CEP 2004-107 - Rev 04
Valid
Bezafibrate
2021-06-15
Japanese DMF

Found JDMF

218MF10019
Bezafibrate "KOA" at Strada Rivolta...
2006-01-27
Written Confirmation

Close WC

Application Number
27497
218MF10019
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
BEZAFIBRATE
Bezafibrate
Bezafibrate "KOA" at Strada Rivolta...
Issue/Submission Date
2013-09-03
2021-06-15
2006-01-27
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USDMF

Found USDMF

10994
Active
BUMETANIDE
1994-07-19
CEP/COS

Found CEP/COS

R1-CEP 1998-151 - Rev 06
Valid
Bumetanide
2021-07-01
Japanese DMF

Found JDMF

218MF10770
BUMETANIDE at Strada Rivoltana Km 6...
2006-09-22
Written Confirmation

Close WC

Application Number
10994
218MF10770
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
BUMETANIDE
Bumetanide
BUMETANIDE at Strada Rivoltana Km 6...
Issue/Submission Date
1994-07-19
2021-07-01
2006-09-22
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USDMF

Found USDMF

30035
Active
DOXORUBICIN HYDROCHLORIDE
2015-11-16
CEP/COS

Found CEP/COS

CEP 2017-169 - Rev 03
Valid
Doxorubicin Hydrochloride
2024-01-17
Japanese DMF

Found JDMF

303MF10121
Doxorubicin Hydrochloride at Strada...
2021-08-02
Written Confirmation

Close WC

Application Number
30035
303MF10121
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
DOXORUBICIN HYDROCHLORIDE
Doxorubicin Hydrochloride
Doxorubicin Hydrochloride at Strada...
Issue/Submission Date
2015-11-16
2024-01-17
2021-08-02
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USDMF

Found USDMF

11899
Active
HYDROXYUREA
1996-03-25
CEP/COS

Found CEP/COS

CEP 2022-263 - Rev 00
Valid
Hydroxycarbamide
2024-01-17
Japanese DMF

Found JDMF

222MF10097
Hydroxyurea at Strada Rivoltana Km ...
2010-03-17
Written Confirmation

Close WC

Application Number
11899
222MF10097
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
HYDROXYUREA
Hydroxycarbamide
Hydroxyurea at Strada Rivoltana Km ...
Issue/Submission Date
1996-03-25
2024-01-17
2010-03-17
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USDMF

Found USDMF

29721
Active
RALOXIFENE HYDROCHLORIDE
2015-09-24
CEP/COS

Found CEP/COS

R1-CEP 2015-171 - Rev 00
Valid
Raloxifene hydrochloride
2022-04-08
Japanese DMF

Found JDMF

303MF10064
Raloxifene Hydrochloride at Strada ...
2021-04-13
Written Confirmation

Close WC

Application Number
29721
303MF10064
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
RALOXIFENE HYDROCHLORIDE
Raloxifene hydrochloride
Raloxifene Hydrochloride at Strada ...
Issue/Submission Date
2015-09-24
2022-04-08
2021-04-13
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USDMF

Found USDMF

7474
Active
TRETINOIN
1988-05-11
CEP/COS

Found CEP/COS

R1-CEP 1998-082 - Rev 07
Valid
Tretinoin
2021-06-18
Japanese DMF

Found JDMF

229MF10001
TRETINOIN type 2 at Strada Rivoltan...
2017-01-10
Written Confirmation

Close WC

Application Number
7474
229MF10001
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
TRETINOIN
Tretinoin
TRETINOIN type 2 at Strada Rivoltan...
Issue/Submission Date
1988-05-11
2021-06-18
2017-01-10
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USDMF

Found USDMF

19920
Active
ARIPIPRAZOLE
2006-11-02
CEP/COS

Found CEP/COS

R1-CEP 2014-188 - Rev 00
Valid
Aripiprazole
2021-06-02
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0197
Expired
Aripiprazole (IH)
2019-09-09
Application Number
19920
Indian CDSCO WC-0197
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-09-08
Filing Details
ARIPIPRAZOLE
Aripiprazole
Aripiprazole (IH)
Issue/Submission Date
2006-11-02
2021-06-02
2019-09-09
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USDMF

Found USDMF

13796
Active
RIFAMPIN
1998-09-01
CEP/COS

Found CEP/COS

R1-CEP 2009-275 - Rev 04
Valid
Rifampicin
2022-07-27
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0197
Expired
Rifampicin (IP/BP/Ph. Eur.)
2019-09-09
Application Number
13796
Indian CDSCO WC-0197
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-09-08
Filing Details
RIFAMPIN
Rifampicin
Rifampicin (IP/BP/Ph. Eur.)
Issue/Submission Date
1998-09-01
2022-07-27
2019-09-09
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USDMF

Found USDMF

17974
Active
RIFAXIMIN
2004-12-14
CEP/COS

Found CEP/COS

R0-CEP 2019-125 - Rev 03
Valid
Rifaximin, Alpha Form
2021-07-05
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0197A3
Expired
Rifaximine Ph.Eur
2020-01-29
Application Number
17974
Indian CDSCO WC-0197A3
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-10-08
Filing Details
RIFAXIMIN
Rifaximin, Alpha Form
Rifaximine Ph.Eur
Issue/Submission Date
2004-12-14
2021-07-05
2020-01-29
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USDMF

Found USDMF

21807
Active
ACAMPROSATE CALCIUM
2008-07-14
CEP/COS

Found CEP/COS

R1-CEP 2009-002 - Rev 07
Valid
Acamprosate calcium
2021-01-15
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
21807
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
ACAMPROSATE CALCIUM
Acamprosate calcium
Issue/Submission Date
2008-07-14
2021-01-15
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USDMF

Found USDMF

17001
Active
ACITRETIN
2003-12-01
CEP/COS

Found CEP/COS

R1-CEP 2005-186 - Rev 08
Valid
Acitretin
2023-05-25
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
17001
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ACITRETIN
Acitretin
Issue/Submission Date
2003-12-01
2023-05-25
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USDMF

Found USDMF

22211
Active
THIOCTIC ACID
2008-11-05
CEP/COS

Found CEP/COS

R1-CEP 2009-004 - Rev 04
Valid
Thioctic acid
2021-07-20
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
22211
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
THIOCTIC ACID
Thioctic acid
Issue/Submission Date
2008-11-05
2021-07-20
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USDMF

Found USDMF

25826
Active
BENDAMUSTINE HCL
2012-02-24
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

301MF10055
Bendamustine Hydrochloride at Strad...
2019-08-29
Written Confirmation

Close WC

Application Number
25826
301MF10055
Status
Active
Fees Paid
N/A
 
Filing Details
BENDAMUSTINE HCL
Bendamustine Hydrochloride at Strad...
Issue/Submission Date
2012-02-24
2019-08-29
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USDMF

Found USDMF

2693
Active
BENZHEXOL HCL. (TRIHEXYPHENIDYL HCL...
1976-06-16
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

219MF10362
Trihexyphenidyl hydrochloride at St...
2007-12-13
Written Confirmation

Close WC

Application Number
2693
219MF10362
Status
Active
Fees Paid
N/A
 
Filing Details
BENZHEXOL HCL. (TRIHEXYPHENIDYL HCL...
Trihexyphenidyl hydrochloride at St...
Issue/Submission Date
1976-06-16
2007-12-13
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USDMF

Found USDMF

19624
Active
BICALUTAMIDE DRUG SUBSTANCE
2006-07-10
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

219MF10221
Bicalutamide at Strada Rivoltana, k...
2007-07-06
Written Confirmation

Close WC

Application Number
19624
219MF10221
Status
Active
Fees Paid
N/A
 
Filing Details
BICALUTAMIDE DRUG SUBSTANCE
Bicalutamide at Strada Rivoltana, k...
Issue/Submission Date
2006-07-10
2007-07-06
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USDMF

Found USDMF

10731
Active
CEFAZOLIN ACID
1993-11-01
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

219MF10322
Cefazolin acid at Strada Rivoltana ...
2007-10-24
Written Confirmation

Close WC

Application Number
10731
219MF10322
Status
Active
Fees Paid
N/A
 
Filing Details
CEFAZOLIN ACID
Cefazolin acid at Strada Rivoltana ...
Issue/Submission Date
1993-11-01
2007-10-24
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2000-297 - Rev 04
Valid
Cefazolin sodium
2018-05-11
Japanese DMF

Found JDMF

219MF10323
Cefazolin sodium at Strada Rivoltan...
2007-10-24
Written Confirmation

Close WC

Application Number
219MF10323
Status
Valid
 
Filing Details
Cefazolin sodium
Cefazolin sodium at Strada Rivoltan...
Issue/Submission Date
2018-05-11
2007-10-24
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USDMF

Found USDMF

30425
Active
DAUNORUBICIN HYDROCHLORIDE
2016-03-21
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

305MF10038
Daunorubicin Hydrochloride at Strad...
2023-03-23
Written Confirmation

Close WC

Application Number
30425
305MF10038
Status
Active
Fees Paid
Reviewed
 
Filing Details
DAUNORUBICIN HYDROCHLORIDE
Daunorubicin Hydrochloride at Strad...
Issue/Submission Date
2016-03-21
2023-03-23
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

CEP 2018-012 - Rev 01
Valid
Epirubicin hydrochloride
2024-03-22
Japanese DMF

Found JDMF

301MF10102
Epirubicin Hydrochloride at Strada ...
2019-12-03
Written Confirmation

Close WC

Application Number
301MF10102
Status
Valid
 
Filing Details
Epirubicin hydrochloride
Epirubicin Hydrochloride at Strada ...
Issue/Submission Date
2024-03-22
2019-12-03
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USDMF

Found USDMF

24032
Active
FENOFIBRATE
2010-08-04
CEP/COS

Found CEP/COS

R1-CEP 2016-036 - Rev 00
Valid
Fenofibrate
2023-01-11
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
24032
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
FENOFIBRATE
Fenofibrate
Issue/Submission Date
2010-08-04
2023-01-11
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USDMF

Found USDMF

15438
Active
FENOFIBRATE
2001-05-08
CEP/COS

Found CEP/COS

R1-CEP 2001-178 - Rev 04
Valid
Fenofibrate
2022-06-15
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
15438
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
FENOFIBRATE
Fenofibrate
Issue/Submission Date
2001-05-08
2022-06-15
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USDMF

Found USDMF

8695
Active
FLUOXETINE HYDROCHLORIDE
1990-08-07
CEP/COS

Found CEP/COS

CEP 2003-231 - Rev 05
Valid
Fluoxetine hydrochloride
2024-02-19
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
8695
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
FLUOXETINE HYDROCHLORIDE
Fluoxetine hydrochloride
Issue/Submission Date
1990-08-07
2024-02-19
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USDMF

Found USDMF

21895
Active
FLUOXETINE HCL EP/USP
2008-08-08
CEP/COS

Found CEP/COS

CEP 2007-033 - Rev 06
Valid
Fluoxetine hydrochloride
2023-12-15
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
21895
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
FLUOXETINE HCL EP/USP
Fluoxetine hydrochloride
Issue/Submission Date
2008-08-08
2023-12-15
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2002-159 - Rev 05
Valid
Flutamide
2017-01-11
Japanese DMF

Found JDMF

217MF11174
Flutamide at Camino de Pliego, No. ...
2005-12-12
Written Confirmation

Close WC

Application Number
217MF11174
Status
Valid
 
Filing Details
Flutamide
Flutamide at Camino de Pliego, No. ...
Issue/Submission Date
2017-01-11
2005-12-12
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2013-110 - Rev 04
Valid
Glycopyrronium bromide
2023-08-23
Japanese DMF

Found JDMF

304MF10139
Glycopyrronium Bromide at Strada Ri...
2022-10-05
Written Confirmation

Close WC

Application Number
304MF10139
Status
Valid
 
Filing Details
Glycopyrronium bromide
Glycopyrronium Bromide at Strada Ri...
Issue/Submission Date
2023-08-23
2022-10-05
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USDMF

Found USDMF

37146
Active
HYDROXYUREA
2022-06-09
CEP/COS

Found CEP/COS

R1-CEP 2003-015 - Rev 05
Valid
Hydroxycarbamide
2023-04-03
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
37146
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
HYDROXYUREA
Hydroxycarbamide
Issue/Submission Date
2022-06-09
2023-04-03
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USDMF

Found USDMF

21500
Active
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
2008-03-29
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

226MF10143
Irinotecan Hydrochloride at Strada ...
2014-07-31
Written Confirmation

Close WC

Application Number
21500
226MF10143
Status
Active
Fees Paid
N/A
 
Filing Details
IRINOTECAN HYDROCHLORIDE TRIHYDRATE
Irinotecan Hydrochloride at Strada ...
Issue/Submission Date
2008-03-29
2014-07-31
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USDMF

Found USDMF

7485
Active
ISOTRETINOIN
1988-05-16
CEP/COS

Found CEP/COS

R1-CEP 1996-082 - Rev 12
Valid
Isotretinoin
2022-04-12
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
7485
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ISOTRETINOIN
Isotretinoin
Issue/Submission Date
1988-05-16
2022-04-12
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USDMF

Found USDMF

14794
Active
KETOCONAZOLE
2001-01-19
CEP/COS

Found CEP/COS

CEP 2016-102 - Rev 03
Valid
Ketoconazole
2023-10-23
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
14794
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
KETOCONAZOLE
Ketoconazole
Issue/Submission Date
2001-01-19
2023-10-23
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USDMF

Found USDMF

10028
Active
LOPERAMIDE HYDROCHLORIDE
1992-12-30
CEP/COS

Found CEP/COS

R1-CEP 2003-149 - Rev 05
Valid
Loperamide hydrochloride
2021-06-15
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10028
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
LOPERAMIDE HYDROCHLORIDE
Loperamide hydrochloride
Issue/Submission Date
1992-12-30
2021-06-15
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USDMF

Found USDMF

24205
Active
MELOXICAM
2010-09-22
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

218MF10765
Meloxicam at Camino Viejo de Pliego...
2006-09-22
Written Confirmation

Close WC

Application Number
24205
218MF10765
Status
Active
Fees Paid
N/A
 
Filing Details
MELOXICAM
Meloxicam at Camino Viejo de Pliego...
Issue/Submission Date
2010-09-22
2006-09-22
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2006-228 - Rev 07
Valid
Miconazole
2023-02-09
Japanese DMF

Found JDMF

228MF10221
Miconazole at Strada Rivoltana Km 6...
2016-11-22
Written Confirmation

Close WC

Application Number
228MF10221
Status
Valid
 
Filing Details
Miconazole
Miconazole at Strada Rivoltana Km 6...
Issue/Submission Date
2023-02-09
2016-11-22
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USDMF

Found USDMF

6693
Active
MINOXIDIL
1986-11-25
CEP/COS

Found CEP/COS

R1-CEP 1996-003 - Rev 09
Valid
Minoxidil
2022-11-24
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
6693
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
MINOXIDIL
Minoxidil
Issue/Submission Date
1986-11-25
2022-11-24
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USDMF

Found USDMF

23745
Active
MOXIFLOXACIN HYDROCHLORIDE
2010-04-23
CEP/COS

Caution CEP/COS

R1-CEP 2010-148 - Rev 01
Withdrawn by Holder
Moxifloxacin hydrochloride
2019-07-02
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0197
Expired
Moxifloxacin Hydrochloride (IH)
2019-09-09
Application Number
23745
Indian CDSCO WC-0197
Status
Active
Fees Paid
N/A
Withdrawn by Holder
 
Expired
2022-09-08
Filing Details
MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin hydrochloride
Moxifloxacin Hydrochloride (IH)
Issue/Submission Date
2010-04-23
2019-07-02
2019-09-09
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USDMF

Found USDMF

35225
Active
NYSTATIN
2020-11-04
CEP/COS

Found CEP/COS

R0-CEP 2020-247 - Rev 00
Valid
Nystatin, Micronised, non-micronise...
2022-10-12
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35225
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
NYSTATIN
Nystatin, Micronised, non-micronise...
Issue/Submission Date
2020-11-04
2022-10-12
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USDMF

Found USDMF

17982
Active
PERGOLIDE MESYLATE
2005-01-12
CEP/COS

Found CEP/COS

R1-CEP 2004-161 - Rev 03
Valid
Pergolide mesilate
2021-09-03
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
17982
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
PERGOLIDE MESYLATE
Pergolide mesilate
Issue/Submission Date
2005-01-12
2021-09-03
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USDMF

Found USDMF

21082
Active
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
2007-11-28
CEP/COS

Caution CEP/COS

R1-CEP 2014-208 - Rev 00
Withdrawn by Holder
Pramipexole dihydrochloride monohyd...
2020-04-16
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0197
Expired
Pramipexole Dihydrochloride Monohyd...
2019-09-09
Application Number
21082
Indian CDSCO WC-0197
Status
Active
Fees Paid
N/A
Withdrawn by Holder
 
Expired
2022-09-08
Filing Details
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
Pramipexole dihydrochloride monohyd...
Pramipexole Dihydrochloride Monohyd...
Issue/Submission Date
2007-11-28
2020-04-16
2019-09-09
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USDMF

Found USDMF

34175
Active
ALBUTEROL SULFATE
2020-02-06
CEP/COS

Found CEP/COS

CEP 2021-191 - Rev 01
Valid
Salbutamol sulfate
2024-02-06
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
34175
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
ALBUTEROL SULFATE
Salbutamol sulfate
Issue/Submission Date
2020-02-06
2024-02-06
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USDMF

Found USDMF

6735
Active
TAMOXIFEN CITRATE
1986-12-15
CEP/COS

Found CEP/COS

R2-CEP 1995-016 - Rev 05
Valid
Tamoxifen citrate
2020-08-20
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
6735
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
TAMOXIFEN CITRATE
Tamoxifen citrate
Issue/Submission Date
1986-12-15
2020-08-20
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USDMF

Found USDMF

32448
Active
TERBINAFINE HYDROCHLORIDE
2018-02-28
CEP/COS

Found CEP/COS

R0-CEP 2017-272 - Rev 03
Valid
Terbinafine hydrochloride
2022-11-03
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
32448
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
TERBINAFINE HYDROCHLORIDE
Terbinafine hydrochloride
Issue/Submission Date
2018-02-28
2022-11-03
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USDMF

Found USDMF

38353
Active
TERBINAFINE HYDROCHLORIDE TYPE-2
2023-07-27
CEP/COS

Found CEP/COS

R0-CEP 2021-256 - Rev 01
Valid
Terbinafine hydrochloride, Type 2
2023-08-22
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
38353
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
TERBINAFINE HYDROCHLORIDE TYPE-2
Terbinafine hydrochloride, Type 2
Issue/Submission Date
2023-07-27
2023-08-22
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USDMF

Found USDMF

25192
Active
TRETINOIN TYPE 2
2011-08-03
CEP/COS

Found CEP/COS

R1-CEP 2010-034 - Rev 01
Valid
Tretinoin, Type 2
2021-07-02
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25192
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
TRETINOIN TYPE 2
Tretinoin, Type 2
Issue/Submission Date
2011-08-03
2021-07-02
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USDMF

Found USDMF

27784
Active
APREPITANT
2013-12-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0197
Expired
Aprepitant
2019-09-09
Application Number
27784
Indian CDSCO WC-0197
Status
Active
Fees Paid
Reviewed
 
Expired
2022-09-08
Filing Details
APREPITANT
Aprepitant
Issue/Submission Date
2013-12-18
2019-09-09
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USDMF

Found USDMF

15148
Active
METFORMIN HYDROCHLORIDE
2000-11-16
CEP/COS

Caution CEP/COS

R1-CEP 2000-306 - Rev 04
Withdrawn by Holder
Metformin Hydrochloride
2014-02-26
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
15148
Status
Active
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
METFORMIN HYDROCHLORIDE
Metformin Hydrochloride
Issue/Submission Date
2000-11-16
2014-02-26
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USDMF

Found USDMF

24346
Active
POSACONAZOLE
2010-11-05
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0197
Expired
Posaconazole (IH)
2019-09-09
Application Number
24346
Indian CDSCO WC-0197
Status
Active
Fees Paid
N/A
 
Expired
2022-09-08
Filing Details
POSACONAZOLE
Posaconazole (IH)
Issue/Submission Date
2010-11-05
2019-09-09
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USDMF

Found USDMF

22841
Active
TIGECYCLINE HYDROCHLORIDE
2009-06-09
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0197
Expired
Tigecycline Hydrochloride
2019-09-09
Application Number
22841
Indian CDSCO WC-0197
Status
Active
Fees Paid
N/A
 
Expired
2022-09-08
Filing Details
TIGECYCLINE HYDROCHLORIDE
Tigecycline Hydrochloride
Issue/Submission Date
2009-06-09
2019-09-09
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