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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Alkem Laboratories Ltd.

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AMLODIPINE BESYLATE USP

APREMILAST

ARIPIPRAZOLE USP

CANAGLIFLOZIN

DALFAMPRIDINE USP

DEXMETHYLPHENIDATE HYDROCHLORIDE

DIMETHYL FUMARATE

DRONEDARONE HYDROCHLORIDE

DULOXETINE HYDROCHLORIDE

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE USP

LAMOTRIGINE

LANSOPRAZOLE USP

METHYLPHENIDATE HYDROCHLORIDE USP

Metformin Hydrochloride (BP)

N-PHENYL-1-(2-PHENYLETHYL)-4-PIPERIDINAMINE

OLANZAPINE USP

Paliperidone (IH)

RABEPRAZOLE SODIUM USP

RASAGILINE MESYLATE

RILUZOLE USP

RIZATRIPTAN BENZOATE USP

SODIUM OXYBATE

TAPENTADOL HYDROCHLORIDE

TOLTERODINE TARTRATE USP

TOLVAPTAN

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Status - Active

Status - Inactive

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WC-0370

WC-0385

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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
AMLODIPINE BESYLATE USP
Issue/Submission Date
2015-09-28
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-0370
Status
Valid - 2019-06-05
Filing Details
Amlodipine Besylate (USP)
Issue/Submission Date
2016-07-04
Supporting Info
Application Number
Indian CDSCO WC-0370
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-06-05
Filing Details
AMLODIPINE BESYLATE USP
Amlodipine Besylate (USP)
Issue/Submission Date
2015-09-28
2016-07-04
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
APREMILAST
Issue/Submission Date
2017-10-03
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
APREMILAST
Issue/Submission Date
2017-10-03
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ARIPIPRAZOLE USP
Issue/Submission Date
2014-02-13
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-0385
Status
Valid - 2019-09-06
Filing Details
Aripiprazole  (USP/EP)
Issue/Submission Date
2016-09-06
Supporting Info
Application Number
Indian CDSCO WC-0385
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-09-06
Filing Details
ARIPIPRAZOLE USP
Aripiprazole  (USP/EP)
Issue/Submission Date
2014-02-13
2016-09-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
CANAGLIFLOZIN
Issue/Submission Date
2016-09-16
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
CANAGLIFLOZIN
Issue/Submission Date
2016-09-16
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DALFAMPRIDINE USP
Issue/Submission Date
2013-11-01
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-0370
Status
Valid - 2019-06-06
Filing Details
Dalfampridine (IH)
Issue/Submission Date
2016-06-06
Supporting Info
Application Number
Indian CDSCO WC-0370
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-06-06
Filing Details
DALFAMPRIDINE USP
Dalfampridine (IH)
Issue/Submission Date
2013-11-01
2016-06-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DEXMETHYLPHENIDATE HYDROCHLORIDE
Issue/Submission Date
2018-06-23
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DEXMETHYLPHENIDATE HYDROCHLORIDE
Issue/Submission Date
2018-06-23
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DIMETHYL FUMARATE
Issue/Submission Date
2016-07-26
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DIMETHYL FUMARATE
Issue/Submission Date
2016-07-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-03-26
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-03-26
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
DULOXETINE HYDROCHLORIDE
Issue/Submission Date
2011-03-17
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-0370
Status
Valid - 2019-06-05
Filing Details
Duloxetine Hydrochlorde USP
Issue/Submission Date
2016-07-04
Supporting Info
Application Number
Indian CDSCO WC-0370
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-06-05
Filing Details
DULOXETINE HYDROCHLORIDE
Duloxetine Hydrochlorde USP
Issue/Submission Date
2011-03-17
2016-07-04
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Issue/Submission Date
2014-10-01
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-0385
Status
Valid - 2019-09-06
Filing Details
Esomeprazole Magnesium Dihydrate (U...
Issue/Submission Date
2016-09-06
Supporting Info
Application Number
Indian CDSCO WC-0385
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-09-06
Filing Details
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Esomeprazole Magnesium Dihydrate (U...
Issue/Submission Date
2014-10-01
2016-09-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
Issue/Submission Date
2016-08-17
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
Issue/Submission Date
2016-08-17
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
LAMOTRIGINE
Issue/Submission Date
2008-03-20
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 - Paid
DMF Review - N/A
 
Filing Details
LAMOTRIGINE
Issue/Submission Date
2008-03-20
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
LANSOPRAZOLE USP
Issue/Submission Date
2011-07-29
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-0370
Status
Valid - 2019-06-06
Filing Details
Lansoprazole (USP)
Issue/Submission Date
2016-06-06
Supporting Info
Application Number
Indian CDSCO WC-0370
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-06-06
Filing Details
LANSOPRAZOLE USP
Lansoprazole (USP)
Issue/Submission Date
2011-07-29
2016-06-06
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-0385
Status
Valid - 2019-09-06
Filing Details
Metformin Hydrochloride (BP)
Issue/Submission Date
2016-09-06
Supporting Info
Application Number
Indian CDSCO WC-0385
Status
 
Valid - 2019-09-06
Filing Details
Metformin Hydrochloride (BP)
Issue/Submission Date
2016-09-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
METHYLPHENIDATE HYDROCHLORIDE USP
Issue/Submission Date
2016-07-29
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
METHYLPHENIDATE HYDROCHLORIDE USP
Issue/Submission Date
2016-07-29
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
N-PHENYL-1-(2-PHENYLETHYL)-4-PIPERI...
Issue/Submission Date
2017-03-20
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
N-PHENYL-1-(2-PHENYLETHYL)-4-PIPERI...
Issue/Submission Date
2017-03-20
Supporting Info
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USDMF

Application Number
Status
Status - Inactive
Facility Fees - Paid
DMF Review - N/A
Filing Details
OLANZAPINE USP
Issue/Submission Date
2010-08-23
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 - Paid
DMF Review - N/A
 
Filing Details
OLANZAPINE USP
Issue/Submission Date
2010-08-23
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-0370
Status
Valid - 2019-06-06
Filing Details
Paliperidone (IH)
Issue/Submission Date
2016-06-06
Supporting Info
Application Number
Indian CDSCO WC-0370
Status
 
Valid - 2019-06-06
Filing Details
Paliperidone (IH)
Issue/Submission Date
2016-06-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
RABEPRAZOLE SODIUM USP
Issue/Submission Date
2013-09-01
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
RABEPRAZOLE SODIUM USP
Issue/Submission Date
2013-09-01
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
RASAGILINE MESYLATE
Issue/Submission Date
2010-04-26
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-0370
Status
Valid - 2019-06-06
Filing Details
Rasagiline Mesylate (IH)
Issue/Submission Date
2016-06-06
Supporting Info
Application Number
Indian CDSCO WC-0370
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-06-06
Filing Details
RASAGILINE MESYLATE
Rasagiline Mesylate (IH)
Issue/Submission Date
2010-04-26
2016-06-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
RILUZOLE USP
Issue/Submission Date
2011-09-24
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
RILUZOLE USP
Issue/Submission Date
2011-09-24
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
RIZATRIPTAN BENZOATE USP
Issue/Submission Date
2011-05-06
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 - Active
Facility Fees - Paid
DMF Review - N/A
 
Filing Details
RIZATRIPTAN BENZOATE USP
Issue/Submission Date
2011-05-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
Filing Details
SODIUM OXYBATE
Issue/Submission Date
2014-06-19
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
Indian CDSCO WC-0370
Status
Valid - 2019-06-05
Filing Details
Sodium Oxybate IH
Issue/Submission Date
2016-07-04
Supporting Info
Application Number
Indian CDSCO WC-0370
Status
Status - Active
Facility Fees - Paid
DMF Review - N/A
 
Valid - 2019-06-05
Filing Details
SODIUM OXYBATE
Sodium Oxybate IH
Issue/Submission Date
2014-06-19
2016-07-04
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
TAPENTADOL HYDROCHLORIDE
Issue/Submission Date
2012-10-23
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-0370
Status
Valid - 2019-06-06
Filing Details
Tapentadole Hydrochloride (IH)
Issue/Submission Date
2016-06-06
Supporting Info
Application Number
Indian CDSCO WC-0370
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
 
Valid - 2019-06-06
Filing Details
TAPENTADOL HYDROCHLORIDE
Tapentadole Hydrochloride (IH)
Issue/Submission Date
2012-10-23
2016-06-06
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
TAPENTADOL HYDROCHLORIDE
Issue/Submission Date
2017-03-27
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
TAPENTADOL HYDROCHLORIDE
Issue/Submission Date
2017-03-27
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
TOLTERODINE TARTRATE USP
Issue/Submission Date
2016-09-30
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
TOLTERODINE TARTRATE USP
Issue/Submission Date
2016-09-30
Supporting Info
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USDMF

Application Number
Status
Status - Active
Facility Fees - Paid
DMF Review - Complete
Filing Details
TOLVAPTAN
Issue/Submission Date
2017-10-06
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 - Active
Facility Fees - Paid
DMF Review - Complete
 
Filing Details
TOLVAPTAN
Issue/Submission Date
2017-10-06
Supporting Info

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