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

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Buclizine hydrochloride (BP)

CARISOPRODOL USP

CYCLOBENZAPRINE HYDROCHLORIDE USP BULK

Cinnarizine

Clopidogrel

Cyclizine

Cyproheptadine Hydrochloride (BP/USP/Ph. Eur)

Diltiazem Hydrochloride

ETODOLAC USP

Etidronate Disodium

Flunarizine HCl

Flunarizine dihydrochloride

Hydroxyzine Hcl

IBANDRONATE SODIUM

Ketotifen Fumarate

Loperamide hydrochloride

MECLIZINE HCL USP

Meclizine Hydrochloride (USP)

Meclozine Hydrochloride (BP/Ph.Eur)

Oxatomide

Penicillamine

Pentoxifylline

Risedronic Acid

Tolterodine

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WITHDRAWN BY EDQM

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WC-0229

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USDMF

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Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Indian CDSCO WC-0229
Status
Valid - 2020-03-16
Filing Details
Buclizine hydrochloride (BP)
Issue/Submission Date
2017-03-16
Application Number
Indian CDSCO WC-0229
Status
 
Valid - 2020-03-16
Filing Details
Buclizine hydrochloride (BP)
Issue/Submission Date
2017-03-16
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CARISOPRODOL USP
Issue/Submission Date
2006-09-26
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Indian CDSCO WC-0229
Status
Valid - 2020-03-16
Filing Details
Carisoprodol (USP/Ph. Eur.)
Issue/Submission Date
2017-03-16
Application Number
Indian CDSCO WC-0229
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Valid - 2020-03-16
Filing Details
CARISOPRODOL USP
Carisoprodol (USP/Ph. Eur.)
Issue/Submission Date
2006-09-26
2017-03-16
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CARISOPRODOL USP
Issue/Submission Date
2017-08-09
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CARISOPRODOL USP
Issue/Submission Date
2017-08-09
Supporting Info
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USDMF

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Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
WITHDRAWN BY EDQM
Filing Details
Cinnarizine
Issue/Submission Date
2009-04-01
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
WITHDRAWN BY EDQM
 
Filing Details
Cinnarizine
Issue/Submission Date
2009-04-01
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USDMF

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Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
VALID
Filing Details
Cinnarizine
Issue/Submission Date
2018-11-09
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
VALID
 
Filing Details
Cinnarizine
Issue/Submission Date
2018-11-09
Supporting Info
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USDMF

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CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
CYCLOBENZAPRINE HYDROCHLORIDE USP B...
Issue/Submission Date
2009-08-19
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
Status - Inactive
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
CYCLOBENZAPRINE HYDROCHLORIDE USP B...
Issue/Submission Date
2009-08-19
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Indian CDSCO WC-0229
Status
Valid - 2020-03-16
Filing Details
Cyproheptadine Hydrochloride (BP/US...
Issue/Submission Date
2017-03-16
Application Number
Indian CDSCO WC-0229
Status
 
Valid - 2020-03-16
Filing Details
Cyproheptadine Hydrochloride (BP/US...
Issue/Submission Date
2017-03-16
Supporting Info
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USDMF

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Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

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CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
ETODOLAC USP
Issue/Submission Date
2017-11-11
CEP/COS

Application Number
Status
VALID
Filing Details
Etodolac
Issue/Submission Date
2018-03-15
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
VALID
 
Filing Details
ETODOLAC USP
Etodolac
Issue/Submission Date
2017-11-11
2018-03-15
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
VALID
Filing Details
Flunarizine dihydrochloride
Issue/Submission Date
2019-03-19
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Application Number
Status
VALID
 
Filing Details
Flunarizine dihydrochloride
Issue/Submission Date
2019-03-19
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
WITHDRAWN BY EDQM
Filing Details
Flunarizine dihydrochloride
Issue/Submission Date
2005-10-03
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0229
Status
Valid - 2020-03-16
Filing Details
Flunarizine Dihydrochloride (BP/Ph....
Issue/Submission Date
2017-03-16
Supporting Info
Application Number
Indian CDSCO WC-0229
Status
WITHDRAWN BY EDQM
 
Valid - 2020-03-16
Filing Details
Flunarizine dihydrochloride
Flunarizine Dihydrochloride (BP/Ph....
Issue/Submission Date
2005-10-03
2017-03-16
Supporting Info
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USDMF

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Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

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Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

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Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
WITHDRAWN BY EDQM
Filing Details
Loperamide hydrochloride
Issue/Submission Date
2010-03-10
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
WITHDRAWN BY EDQM
 
Filing Details
Loperamide hydrochloride
Issue/Submission Date
2010-03-10
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
VALID
Filing Details
Loperamide hydrochloride
Issue/Submission Date
2019-01-04
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Indian CDSCO WC-0229
Status
Valid - 2020-03-16
Filing Details
Loperamide Hydrochloride (BP/USP/Ph...
Issue/Submission Date
2017-03-16
Application Number
Indian CDSCO WC-0229
Status
VALID
 
Valid - 2020-03-16
Filing Details
Loperamide hydrochloride
Loperamide Hydrochloride (BP/USP/Ph...
Issue/Submission Date
2019-01-04
2017-03-16
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
Filing Details
MECLIZINE HCL USP
Issue/Submission Date
2007-04-23
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
Status - Active
Facility Fees - Unpaid
DMF Review - N/A
 
Filing Details
MECLIZINE HCL USP
Issue/Submission Date
2007-04-23
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0229
Status
Valid - 2020-03-16
Filing Details
Meclizine Hydrochloride (USP)
Issue/Submission Date
2017-03-16
Supporting Info
Application Number
Indian CDSCO WC-0229
Status
 
Valid - 2020-03-16
Filing Details
Meclizine Hydrochloride (USP)
Issue/Submission Date
2017-03-16
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Supporting Info
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
Written Confirmation

Application Number
Indian CDSCO WC-0229
Status
Valid - 2020-03-16
Filing Details
Meclozine Hydrochloride (BP/Ph.Eur)
Issue/Submission Date
2017-03-16
Supporting Info
Application Number
Indian CDSCO WC-0229
Status
 
Valid - 2020-03-16
Filing Details
Meclozine Hydrochloride (BP/Ph.Eur)
Issue/Submission Date
2017-03-16
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

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Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

Application Number
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Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info
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USDMF

Application Number
Status
Filing Details
Issue/Submission Date
CEP/COS

Application Number
Status
Filing Details
Issue/Submission Date
Japanese DMF

Application Number
Status
 
Filing Details
Issue/Submission Date
Written Confirmation

Application Number
Status
Filing Details
Issue/Submission Date
Application Number
Status
 
Filing Details
Issue/Submission Date
Supporting Info

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