Athena Athena

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

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Alkem Laboratories
india-flag Flag
Country
Country
India
Address
Address
Devashish Building, Alkem House, Senapati Bapat Road, Lower Parel, Mumbai - 400 013
Telephone
Telephone

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USDMF

Found USDMF

29703
Active
AMLODIPINE BESYLATE USP
2015-09-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Amlodipine Besylate (USP)
2022-09-30
Application Number
29703
Indian CDSCO WC-0370
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-05
Filing Details
AMLODIPINE BESYLATE USP
Amlodipine Besylate (USP)
Issue/Submission Date
2015-09-28
2022-09-30
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USDMF

Found USDMF

24685
Active
DULOXETINE HYDROCHLORIDE
2011-03-17
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Duloxetine Hydrochlorde USP
2022-09-30
Application Number
24685
Indian CDSCO WC-0370
Status
Active
Fees Paid
N/A
 
Valid
2025-06-05
Filing Details
DULOXETINE HYDROCHLORIDE
Duloxetine Hydrochlorde USP
Issue/Submission Date
2011-03-17
2022-09-30
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USDMF

Found USDMF

27637
Active
DALFAMPRIDINE USP
2013-11-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Dalfampridine IH
2022-09-30
Application Number
27637
Indian CDSCO WC-0370
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-05
Filing Details
DALFAMPRIDINE USP
Dalfampridine IH
Issue/Submission Date
2013-11-01
2022-09-30
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USDMF

Found USDMF

25152
Active
LANSOPRAZOLE USP
2011-07-29
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Lansoprazole (USP)
2022-09-30
Application Number
25152
Indian CDSCO WC-0370
Status
Active
Fees Paid
N/A
 
Valid
2025-06-05
Filing Details
LANSOPRAZOLE USP
Lansoprazole (USP)
Issue/Submission Date
2011-07-29
2022-09-30
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USDMF

Found USDMF

23679
Active
RASAGILINE MESYLATE
2010-04-26
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Rasagiline Mesylate (IH)
2022-09-30
Application Number
23679
Indian CDSCO WC-0370
Status
Active
Fees Paid
N/A
 
Valid
2025-06-05
Filing Details
RASAGILINE MESYLATE
Rasagiline Mesylate (IH)
Issue/Submission Date
2010-04-26
2022-09-30
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USDMF

Found USDMF

25260
Active
RILUZOLE USP
2011-09-24
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Riluzole USP
2022-09-30
Application Number
25260
Indian CDSCO WC-0370
Status
Active
Fees Paid
N/A
 
Valid
2025-06-05
Filing Details
RILUZOLE USP
Riluzole USP
Issue/Submission Date
2011-09-24
2022-09-30
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USDMF

Found USDMF

24884
Active
RIZATRIPTAN BENZOATE USP
2011-05-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Rizatriptan Benzoate USP
2022-09-30
Application Number
24884
Indian CDSCO WC-0370
Status
Active
Fees Paid
N/A
 
Valid
2025-06-05
Filing Details
RIZATRIPTAN BENZOATE USP
Rizatriptan Benzoate USP
Issue/Submission Date
2011-05-06
2022-09-30
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USDMF

Found USDMF

28289
Active
SODIUM OXYBATE
2014-06-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Sodium Oxybate IH
2022-09-30
Application Number
28289
Indian CDSCO WC-0370
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-05
Filing Details
SODIUM OXYBATE
Sodium Oxybate IH
Issue/Submission Date
2014-06-19
2022-09-30
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USDMF

Found USDMF

26519
Active
TAPENTADOL HYDROCHLORIDE
2012-10-23
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Tapentadole Hydrochloride (IH)
2022-09-30
Application Number
26519
Indian CDSCO WC-0370
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-05
Filing Details
TAPENTADOL HYDROCHLORIDE
Tapentadole Hydrochloride (IH)
Issue/Submission Date
2012-10-23
2022-09-30
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USDMF

Found USDMF

27909
Active
ARIPIPRAZOLE USP
2014-02-13
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0385
Expired
Aripiprazole  (USP/EP)
2020-03-13
Application Number
27909
Indian CDSCO WC-0385
Status
Active
Fees Paid
Reviewed
 
Expired
2022-09-05
Filing Details
ARIPIPRAZOLE USP
Aripiprazole  (USP/EP)
Issue/Submission Date
2014-02-13
2020-03-13
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USDMF

Found USDMF

31435
Active
TAPENTADOL HYDROCHLORIDE
2017-03-27
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-037a1
Expired
Tapentadol Hydrochloride IH
2019-11-18
Application Number
31435
Indian CDSCO WC-037a1
Status
Active
Fees Paid
Reviewed
 
Expired
2022-06-05
Filing Details
TAPENTADOL HYDROCHLORIDE
Tapentadol Hydrochloride IH
Issue/Submission Date
2017-03-27
2019-11-18
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USDMF

Found USDMF

35610
Active
AMLODIPINE BENZOATE
2021-03-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35610
Status
Active
Fees Paid
N/A
 
Filing Details
AMLODIPINE BENZOATE
Issue/Submission Date
2021-03-31
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USDMF

Found USDMF

32114
Active
APREMILAST
2017-10-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
32114
Status
Active
Fees Paid
Reviewed
 
Filing Details
APREMILAST
Issue/Submission Date
2017-10-03
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USDMF

Found USDMF

38047
Active
AZILSARTAN KAMEDOXOMIL
2023-09-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
38047
Status
Active
Fees Paid
N/A
 
Filing Details
AZILSARTAN KAMEDOXOMIL
Issue/Submission Date
2023-09-12
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USDMF

Found USDMF

38713
Active
BEMPEDOIC ACID
2023-08-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
38713
Status
Active
Fees Paid
Reviewed
 
Filing Details
BEMPEDOIC ACID
Issue/Submission Date
2023-08-31
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USDMF

Found USDMF

30941
Active
CANAGLIFLOZIN
2016-09-16
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
30941
Status
Active
Fees Paid
Reviewed
 
Filing Details
CANAGLIFLOZIN
Issue/Submission Date
2016-09-16
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USDMF

Found USDMF

36744
Active
CANNABIDIOL
2022-02-08
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36744
Status
Active
Fees Paid
Reviewed
 
Filing Details
CANNABIDIOL
Issue/Submission Date
2022-02-08
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USDMF

Found USDMF

31408
Active
N-PHENYL-1-(2-PHENYLETHYL)-4-PIPERI...
2017-03-20
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
31408
Status
Active
Fees Paid
N/A
 
Filing Details
N-PHENYL-1-(2-PHENYLETHYL)-4-PIPERI...
Issue/Submission Date
2017-03-20
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USDMF

Found USDMF

32902
Active
DEXMETHYLPHENIDATE HYDROCHLORIDE
2018-06-23
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
32902
Status
Active
Fees Paid
Reviewed
 
Filing Details
DEXMETHYLPHENIDATE HYDROCHLORIDE
Issue/Submission Date
2018-06-23
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USDMF

Found USDMF

30622
Active
DIMETHYL FUMARATE
2016-07-26
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
30622
Status
Active
Fees Paid
Reviewed
 
Filing Details
DIMETHYL FUMARATE
Issue/Submission Date
2016-07-26
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USDMF

Found USDMF

26901
Active
DRONEDARONE HYDROCHLORIDE
2013-03-26
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
26901
Status
Active
Fees Paid
Reviewed
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-03-26
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USDMF

Found USDMF

33372
Active
ELUXADOLINE
2019-01-02
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
33372
Status
Active
Fees Paid
Reviewed
 
Filing Details
ELUXADOLINE
Issue/Submission Date
2019-01-02
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USDMF

Found USDMF

37461
Active
ESKETAMINE HYDROCHLORIDE
2022-09-26
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
37461
Status
Active
Fees Paid
Reviewed
 
Filing Details
ESKETAMINE HYDROCHLORIDE
Issue/Submission Date
2022-09-26
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USDMF

Found USDMF

28581
Active
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
2014-10-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28581
Status
Active
Fees Paid
Reviewed
 
Filing Details
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Issue/Submission Date
2014-10-01
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USDMF

Found USDMF

30787
Active
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
2016-08-17
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
30787
Status
Active
Fees Paid
Reviewed
 
Filing Details
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE U...
Issue/Submission Date
2016-08-17
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USDMF

Found USDMF

35298
Active
LANTHANUM CARBONATE OCTAHYDRATE
2020-10-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35298
Status
Active
Fees Paid
Reviewed
 
Filing Details
LANTHANUM CARBONATE OCTAHYDRATE
Issue/Submission Date
2020-10-21
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USDMF

Found USDMF

36325
Active
Bis-Boc-Lisdexaetamine
2021-10-25
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36325
Status
Active
Fees Paid
N/A
 
Filing Details
Bis-Boc-Lisdexaetamine
Issue/Submission Date
2021-10-25
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USDMF

Found USDMF

38667
Active
LISDEXAETAMINE DIMESYLATE
2023-08-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
38667
Status
Active
Fees Paid
N/A
 
Filing Details
LISDEXAETAMINE DIMESYLATE
Issue/Submission Date
2023-08-03
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USDMF

Found USDMF

33939
Active
MESALAMINE USP
2019-07-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
33939
Status
Active
Fees Paid
Reviewed
 
Filing Details
MESALAMINE USP
Issue/Submission Date
2019-07-06
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USDMF

Found USDMF

30682
Active
METHYLPHENIDATE HYDROCHLORIDE USP
2016-07-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
30682
Status
Active
Fees Paid
Reviewed
 
Filing Details
METHYLPHENIDATE HYDROCHLORIDE USP
Issue/Submission Date
2016-07-29
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0370
Valid
Paliperidone (IH)
2022-09-30
Application Number
Indian CDSCO WC-0370
Status
 
Valid
2025-06-05
Filing Details
Paliperidone (IH)
Issue/Submission Date
2022-09-30
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USDMF

Found USDMF

27403
Active
RABEPRAZOLE SODIUM USP
2013-09-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
27403
Status
Active
Fees Paid
Reviewed
 
Filing Details
RABEPRAZOLE SODIUM USP
Issue/Submission Date
2013-09-01
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USDMF

Found USDMF

36599
Active
RITALINIC ACID
2021-12-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36599
Status
Active
Fees Paid
N/A
 
Filing Details
RITALINIC ACID
Issue/Submission Date
2021-12-21
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USDMF

Found USDMF

36951
Active
Solriaetol Hydrochloride
2022-03-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36951
Status
Active
Fees Paid
Reviewed
 
Filing Details
Solriaetol Hydrochloride
Issue/Submission Date
2022-03-28
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USDMF

Found USDMF

30994
Active
TOLTERODINE TARTRATE USP
2016-09-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
30994
Status
Active
Fees Paid
Reviewed
 
Filing Details
TOLTERODINE TARTRATE USP
Issue/Submission Date
2016-09-30
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USDMF

Found USDMF

32030
Active
TOLVAPTAN
2017-10-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
32030
Status
Active
Fees Paid
Reviewed
 
Filing Details
TOLVAPTAN
Issue/Submission Date
2017-10-06
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MED-300179/E (INTERMEDIATE)

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USDMF

Found USDMF

28119
Active
MED-300179/E (INTERMEDIATE)
2014-04-16
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28119
Status
Active
Fees Paid
N/A
 
Filing Details
MED-300179/E (INTERMEDIATE)
Issue/Submission Date
2014-04-16
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-037a1
Expired
Amlodipine Besilate USP
2019-11-18
Application Number
Indian CDSCO WC-037a1
Status
 
Expired
2022-06-05
Filing Details
Amlodipine Besilate USP
Issue/Submission Date
2019-11-18
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0385
Expired
Benzoyl Peroxide Hydrous USP
2020-03-13
Application Number
Indian CDSCO WC-0385
Status
 
Expired
2022-09-05
Filing Details
Benzoyl Peroxide Hydrous USP
Issue/Submission Date
2020-03-13
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-037a1
Expired
Duloxetine Hydrochloride USP
2019-11-18
Application Number
Indian CDSCO WC-037a1
Status
 
Expired
2022-06-05
Filing Details
Duloxetine Hydrochloride USP
Issue/Submission Date
2019-11-18
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USDMF

Caution USDMF

21390
Inactive
LAMOTRIGINE
2008-03-20
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
21390
Status
Inactive
Fees Paid
N/A
 
Filing Details
LAMOTRIGINE
Issue/Submission Date
2008-03-20
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-037a1
Expired
Lansoprazole USP
2019-11-18
Application Number
Indian CDSCO WC-037a1
Status
 
Expired
2022-06-05
Filing Details
Lansoprazole USP
Issue/Submission Date
2019-11-18
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USDMF

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24016
Inactive
OLANZAPINE USP
2010-08-23
CEP/COS

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Application Number
24016
Status
Inactive
Fees Paid
N/A
 
Filing Details
OLANZAPINE USP
Issue/Submission Date
2010-08-23
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USDMF

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CEP/COS

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Indian CDSCO WC-037a1
Expired
Paliperidone IH
2019-11-18
Application Number
Indian CDSCO WC-037a1
Status
 
Expired
2022-06-05
Filing Details
Paliperidone IH
Issue/Submission Date
2019-11-18
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CEP/COS

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Indian CDSCO WC-037a1
Expired
Rasagiline Mesylate IH
2019-11-18
Application Number
Indian CDSCO WC-037a1
Status
 
Expired
2022-06-05
Filing Details
Rasagiline Mesylate IH
Issue/Submission Date
2019-11-18
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CEP/COS

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Indian CDSCO WC-0370A3
Expired
Riluzole USP
2020-06-28
Application Number
Indian CDSCO WC-0370A3
Status
 
Expired
2022-06-05
Filing Details
Riluzole USP
Issue/Submission Date
2020-06-28
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CEP/COS

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Indian CDSCO WC-0370A3
Expired
Rizatriptan Benzoate USP
2020-06-28
Application Number
Indian CDSCO WC-0370A3
Status
 
Expired
2022-06-05
Filing Details
Rizatriptan Benzoate USP
Issue/Submission Date
2020-06-28
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