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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Fdc Limited

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01 Betaxolol (1)

02 Brimonidine Tartrate (1)

03 Bromhexine Hydrochloride (1)

04 Cinnarizine (1)

05 Dantrolene (1)

06 Diazepam (1)

07 Dorzolamide Hydrochloride (2)

08 Econazole Nitrate (1)

09 Fluconazole (1)

10 Flunarizine (1)

11 Flurbiprofen (2)

12 Flurbiprofen Sodium (1)

13 Ketoconazole (1)

14 Latanoprost (1)

15 Levalbuterol Hydrochloride (1)

16 Metaxalone (1)

17 Metronidazole (1)

18 Miconazole (1)

19 Miconazole Nitrate (1)

20 Olopatadine Hydrochloride (1)

21 Rupatadine Fumarate (1)

22 Salbutamol Sulphate (1)

23 Telmisartan (1)

24 Timolol Maleate (1)

25 Blank (2)

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01 Active (10)

02 Inactive (12)

03 Blank (6)

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01 Valid (14)

02 Blank (14)

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01 218MF10559 (1)

02 219MF10187 (1)

03 227MF10140 (1)

04 305MF10115 (1)

05 Blank (24)

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01 WC-0055 (17)

02 Blank (11)

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USDMF

Found USDMF

8219
Active
FLURBIPROFEN USP
1989-09-07
CEP/COS

Found CEP/COS

R0-CEP 2022-382 - Rev 00
Valid
Flurbiprofen, Process 2
2023-01-26
Japanese DMF

Found JDMF

219MF10187
FLURBIPROFEN at 142-48,s,v,road,jog...
2007-06-01
Written Confirmation

Found WC

Indian CDSCO WC-0055
Valid
Flurbiprofen (BP/USP/EP/IP/JP)
2022-06-08
Application Number
8219
219MF10187
Indian CDSCO WC-0055
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-07
Filing Details
FLURBIPROFEN USP
Flurbiprofen, Process 2
FLURBIPROFEN at 142-48,s,v,road,jog...
Flurbiprofen (BP/USP/EP/IP/JP)
Issue/Submission Date
1989-09-07
2023-01-26
2007-06-01
2022-06-08
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USDMF

Found USDMF

9839
Active
TIMOLOL MALEATE USP
1992-07-27
CEP/COS

Found CEP/COS

R1-CEP 2003-070 - Rev 03
Valid
Timolol maleate
2020-09-15
Japanese DMF

Found JDMF

227MF10140
Timolol maleate at 142-48,s,v,road,...
2015-05-14
Written Confirmation

Found WC

Indian CDSCO WC-0055
Valid
Timolol Maleate (BP/EP/USP/IP/JP)
2022-06-08
Application Number
9839
227MF10140
Indian CDSCO WC-0055
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
TIMOLOL MALEATE USP
Timolol maleate
Timolol maleate at 142-48,s,v,road,...
Timolol Maleate (BP/EP/USP/IP/JP)
Issue/Submission Date
1992-07-27
2020-09-15
2015-05-14
2022-06-08
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USDMF

Found USDMF

20855
Active
BRIMONIDINE TARTRATE USP
2007-09-17
CEP/COS

Found CEP/COS

R0-CEP 2020-123 - Rev 00
Valid
Brimonidine tartrate
2022-06-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0055
Valid
Brimonidine Tartrate (IH/IP/EP)
2022-06-08
Application Number
20855
Indian CDSCO WC-0055
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-07
Filing Details
BRIMONIDINE TARTRATE USP
Brimonidine tartrate
Brimonidine Tartrate (IH/IP/EP)
Issue/Submission Date
2007-09-17
2022-06-13
2022-06-08
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2007-032 - Rev 03
Valid
Bromhexine hydrochloride
2023-01-23
Japanese DMF

Found JDMF

305MF10115
Bromhexine Hydrochloride at 142-48,...
2023-10-12
Written Confirmation

Found WC

Indian CDSCO WC-0055
Valid
Bromhexine Hydrochloride (BP/EP/IP/...
2022-06-08
Application Number
305MF10115
Indian CDSCO WC-0055
Status
Valid
 
Valid
2025-07-07
Filing Details
Bromhexine hydrochloride
Bromhexine Hydrochloride at 142-48,...
Bromhexine Hydrochloride (BP/EP/IP/...
Issue/Submission Date
2023-01-23
2023-10-12
2022-06-08
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USDMF

Found USDMF

31934
Active
CINNARIZINE
2017-09-07
CEP/COS

Found CEP/COS

CEP 2003-150 - Rev 03
Valid
Cinnarizine
2023-09-08
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0055
Valid
Cinnarizine (BP/EP/IP)
2022-06-08
Application Number
31934
Indian CDSCO WC-0055
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-07
Filing Details
CINNARIZINE
Cinnarizine
Cinnarizine (BP/EP/IP)
Issue/Submission Date
2017-09-07
2023-09-08
2022-06-08
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USDMF

Found USDMF

10456
Active
ECONAZOLE NITRATE USP
1993-08-09
CEP/COS

Found CEP/COS

R1-CEP 2003-133 - Rev 01
Valid
Econazole nitrate
2021-03-12
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0055
Valid
Econazole Nitrate (BP/EP)
2022-06-08
Application Number
10456
Indian CDSCO WC-0055
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-07
Filing Details
ECONAZOLE NITRATE USP
Econazole nitrate
Econazole Nitrate (BP/EP)
Issue/Submission Date
1993-08-09
2021-03-12
2022-06-08
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USDMF

Found USDMF

7376
Active
MICONAZOLE NITRATE USP
1988-03-04
CEP/COS

Found CEP/COS

R1-CEP 1998-146 - Rev 03
Valid
Miconazole nitrate
2020-08-18
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0055
Valid
Miconazole Nitrate (BP/EP/USP)
2022-06-08
Application Number
7376
Indian CDSCO WC-0055
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
MICONAZOLE NITRATE USP
Miconazole nitrate
Miconazole Nitrate (BP/EP/USP)
Issue/Submission Date
1988-03-04
2020-08-18
2022-06-08
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USDMF

Found USDMF

7809
Active
ALBUTEROL SULFATE USP
1988-12-12
CEP/COS

Found CEP/COS

CEP 2015-212 - Rev 01
Valid
Salbutamol sulfate
2024-02-01
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0055
Valid
Salbutamol Sulfate (BP/EP)/Albutero...
2022-06-08
Application Number
7809
Indian CDSCO WC-0055
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-07
Filing Details
ALBUTEROL SULFATE USP
Salbutamol sulfate
Salbutamol Sulfate (BP/EP)/Albutero...
Issue/Submission Date
1988-12-12
2024-02-01
2022-06-08
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USDMF

Caution USDMF

20856
Inactive
DORZOLAMIDE HYDROCHLORIDE USP
2007-09-17
CEP/COS

Found CEP/COS

CEP 2023-236 - Rev 00
Valid
Dorzolamide hydrochloride, Process ...
2023-09-07
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0055
Valid
Dorzolamide Hydrochloride (EP/BP)
2022-06-08
Application Number
20856
Indian CDSCO WC-0055
Status
Inactive
Fees Paid
N/A
Valid
 
Valid
2025-07-07
Filing Details
DORZOLAMIDE HYDROCHLORIDE USP
Dorzolamide hydrochloride, Process ...
Dorzolamide Hydrochloride (EP/BP)
Issue/Submission Date
2007-09-17
2023-09-07
2022-06-08
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USDMF

Caution USDMF

16632
Inactive
FLUCONAZOLE
2003-06-12
CEP/COS

Found CEP/COS

R1-CEP 2016-286 - Rev 00
Valid
Fluconazole
2023-07-04
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0055
Valid
Fluconazole (EP/USP)
2022-06-08
Application Number
16632
Indian CDSCO WC-0055
Status
Inactive
Fees Paid
N/A
Valid
 
Valid
2025-07-07
Filing Details
FLUCONAZOLE
Fluconazole
Fluconazole (EP/USP)
Issue/Submission Date
2003-06-12
2023-07-04
2022-06-08
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