Athena Athena

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Hetero Drugs Limited (Unit IX)

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Hetero Drugs
india-flag Flag
Country
Country
India
Address
Address
7-2-A2, Hetero Corporate Industrial Estates, Sanath Nagar Hyderabad,Telangana
Telephone
Telephone
+91 40 23704923/24
Linkedin
Linkedin
Twitter
Twitter

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ListList of Products
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USDMF

Found USDMF

22231
Active
ANASTROZOLE USP
2008-12-01
CEP/COS

Found CEP/COS

R1-CEP 2013-172 - Rev 01
Valid
Anastrozole
2020-12-15
Japanese DMF

Found JDMF

228MF10140
Anastrozole at 7-2-A2,Hetero Corpor...
2016-08-02
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Anastrozole (IH/USP/Ph. Eur)
2022-09-16
Application Number
22231
228MF10140
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
ANASTROZOLE USP
Anastrozole
Anastrozole at 7-2-A2,Hetero Corpor...
Anastrozole (IH/USP/Ph. Eur)
Issue/Submission Date
2008-12-01
2020-12-15
2016-08-02
2022-09-16
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USDMF

Found USDMF

22563
Active
ARIPIPRAZOLE PROCESS II
2009-02-23
CEP/COS

Found CEP/COS

R0-CEP 2017-254 - Rev 02
Valid
Aripiprazole, Process-II
2022-06-01
Japanese DMF

Found JDMF

306MF10017
Aripiprazole at 7-2-A2,Hetero Corp...
2024-01-24
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Aripiprazole (IH)
2022-09-16
Application Number
22563
306MF10017
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
ARIPIPRAZOLE PROCESS II
Aripiprazole, Process-II
Aripiprazole at 7-2-A2,Hetero Corp...
Aripiprazole (IH)
Issue/Submission Date
2009-02-23
2022-06-01
2024-01-24
2022-09-16
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USDMF

Found USDMF

20246
Active
ATOMOXETINE HYDROCHLORIDE
2007-02-07
CEP/COS

Found CEP/COS

R0-CEP 2020-091 - Rev 01
Valid
Atomoxetine hydrochloride, Process-...
2021-03-19
Japanese DMF

Found JDMF

229MF10156
Atomoxetine hydrochloride at 7-2-A2...
2017-08-08
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Atomoxetine Hydrochloride (IH)
2022-09-16
Application Number
20246
229MF10156
Indian CDSCO WC-0041
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-08-08
Filing Details
ATOMOXETINE HYDROCHLORIDE
Atomoxetine hydrochloride, Process-...
Atomoxetine hydrochloride at 7-2-A2...
Atomoxetine Hydrochloride (IH)
Issue/Submission Date
2007-02-07
2021-03-19
2017-08-08
2022-09-16
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USDMF

Found USDMF

26122
Active
ATORVASTATIN CALCIUM TRIHYDRATE (FO...
2012-06-04
CEP/COS

Found CEP/COS

R0-CEP 2018-049 - Rev 01
Valid
Atorvastatin calcium, Form-I
2023-03-24
Japanese DMF

Found JDMF

229MF10202
Atorvastatin calcium hydrate [Form-...
2017-11-20
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Atorvastatin Calcium Trihydrate (Ph...
2022-09-16
Application Number
26122
229MF10202
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
ATORVASTATIN CALCIUM TRIHYDRATE (FO...
Atorvastatin calcium, Form-I
Atorvastatin calcium hydrate [Form-...
Atorvastatin Calcium Trihydrate (Ph...
Issue/Submission Date
2012-06-04
2023-03-24
2017-11-20
2022-09-16
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USDMF

Found USDMF

18496
Active
BICALUTAMIDE (FORM-H1)
2005-07-07
CEP/COS

Found CEP/COS

R1-CEP 2012-254 - Rev 02
Valid
Bicalutamide, Form-H1
2023-01-09
Japanese DMF

Found JDMF

226MF10046
Bicalutamide "BT" at 7-2-A2,Hetero ...
2014-02-20
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Bicalutamide (USP & Ph Eur)
2022-09-16
Application Number
18496
226MF10046
Indian CDSCO WC-0041
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-08-08
Filing Details
BICALUTAMIDE (FORM-H1)
Bicalutamide, Form-H1
Bicalutamide "BT" at 7-2-A2,Hetero ...
Bicalutamide (USP & Ph Eur)
Issue/Submission Date
2005-07-07
2023-01-09
2014-02-20
2022-09-16
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USDMF

Found USDMF

22140
Active
CAPECITABINE, USP
2008-10-27
CEP/COS

Found CEP/COS

R1-CEP 2014-355 - Rev 02
Valid
Capecitabine
2023-06-16
Japanese DMF

Found JDMF

228MF10215
Capecitabine at 7-2-A2,Hetero Corpo...
2016-11-09
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Capecitabine (IH/USP)
2022-09-16
Application Number
22140
228MF10215
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
CAPECITABINE, USP
Capecitabine
Capecitabine at 7-2-A2,Hetero Corpo...
Capecitabine (IH/USP)
Issue/Submission Date
2008-10-27
2023-06-16
2016-11-09
2022-09-16
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USDMF

Found USDMF

21018
Active
DONEPEZIL HYDROCHLORIDE (MONOHYDRAT...
2007-11-07
CEP/COS

Found CEP/COS

CEP 2022-301 - Rev 01
Valid
Donepezil hydrochloride monohydrate...
2023-12-15
Japanese DMF

Found JDMF

222MF10202
Donepezil hydrochloride at 7-2-A2, ...
2010-07-14
Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Donepezil Hydrochloride (IH/USP)
2022-07-04
Application Number
21018
222MF10202
Indian CDSCO WC-0040
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-03
Filing Details
DONEPEZIL HYDROCHLORIDE (MONOHYDRAT...
Donepezil hydrochloride monohydrate...
Donepezil hydrochloride at 7-2-A2, ...
Donepezil Hydrochloride (IH/USP)
Issue/Submission Date
2007-11-07
2023-12-15
2010-07-14
2022-07-04
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USDMF

Found USDMF

25280
Active
DULOXETINE HYDROCHLORIDE
2011-09-12
CEP/COS

Found CEP/COS

R1-CEP 2012-305 - Rev 02
Valid
Duloxetine hydrochloride
2023-01-12
Japanese DMF

Found JDMF

302MF10022
Duloxetine hydrochloride "K" at 7-2...
2020-02-06
Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Duloxetine Hydrochloride (Ph. Eur/I...
2022-07-04
Application Number
25280
302MF10022
Indian CDSCO WC-0040
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-03
Filing Details
DULOXETINE HYDROCHLORIDE
Duloxetine hydrochloride
Duloxetine hydrochloride "K" at 7-2...
Duloxetine Hydrochloride (Ph. Eur/I...
Issue/Submission Date
2011-09-12
2023-01-12
2020-02-06
2022-07-04
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USDMF

Found USDMF

27774
Active
DUTASTERIDE
2013-12-11
CEP/COS

Found CEP/COS

R1-CEP 2016-126 - Rev 00
Valid
Dutasteride
2022-07-26
Japanese DMF

Found JDMF

231MF10024
Dutasteride "K" at 7-2-A2,Hetero Co...
2019-02-05
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Dutasteride (IH/USP/Ph. Eur)
2022-09-16
Application Number
27774
231MF10024
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
DUTASTERIDE
Dutasteride
Dutasteride "K" at 7-2-A2,Hetero Co...
Dutasteride (IH/USP/Ph. Eur)
Issue/Submission Date
2013-12-11
2022-07-26
2019-02-05
2022-09-16
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USDMF

Found USDMF

33832
Active
EPLERENONE
2019-05-20
CEP/COS

Found CEP/COS

CEP 2019-263 - Rev 02
Valid
Eplerenone
2024-03-05
Japanese DMF

Found JDMF

304MF10031
Eplerenone at 7-2-A2,Hetero Corpora...
2022-02-10
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Eplerenone IH/EP
2022-09-16
Application Number
33832
304MF10031
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
EPLERENONE
Eplerenone
Eplerenone at 7-2-A2,Hetero Corpora...
Eplerenone IH/EP
Issue/Submission Date
2019-05-20
2024-03-05
2022-02-10
2022-09-16
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USDMF

Found USDMF

17960
Active
ESCITALOPRAM OXALATE (PROCESS-I)
2004-12-29
CEP/COS

Found CEP/COS

R1-CEP 2016-306 - Rev 00
Valid
Escitalopram oxalate, Process I
2023-05-23
Japanese DMF

Found JDMF

303MF10125
Escitalopram Oxalate at 7-2-A2,Hete...
2021-08-16
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Escitalopram Oxalate (IH/USP)
2022-09-16
Application Number
17960
303MF10125
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
ESCITALOPRAM OXALATE (PROCESS-I)
Escitalopram oxalate, Process I
Escitalopram Oxalate at 7-2-A2,Hete...
Escitalopram Oxalate (IH/USP)
Issue/Submission Date
2004-12-29
2023-05-23
2021-08-16
2022-09-16
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USDMF

Found USDMF

20893
Active
FINASTERIDE
2007-09-27
CEP/COS

Found CEP/COS

R1-CEP 2011-351 - Rev 02
Valid
Finasteride
2023-07-10
Japanese DMF

Found JDMF

227MF10060
Finasteride at 7-2-A2,Hetero Corpor...
2015-03-06
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Finasteride (USP/Ph.Eur)
2022-09-16
Application Number
20893
227MF10060
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
FINASTERIDE
Finasteride
Finasteride at 7-2-A2,Hetero Corpor...
Finasteride (USP/Ph.Eur)
Issue/Submission Date
2007-09-27
2023-07-10
2015-03-06
2022-09-16
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USDMF

Found USDMF

32274
Active
GEFITINIB
2017-12-28
CEP/COS

Found CEP/COS

R0-CEP 2018-031 - Rev 00
Valid
Gefitinib
2019-11-19
Japanese DMF

Found JDMF

230MF10026
Gefitinib at 7-2-A2,Hetero Corporat...
2018-02-15
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Gefitinib (1H)
2022-09-16
Application Number
32274
230MF10026
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
GEFITINIB
Gefitinib
Gefitinib at 7-2-A2,Hetero Corporat...
Gefitinib (1H)
Issue/Submission Date
2017-12-28
2019-11-19
2018-02-15
2022-09-16
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USDMF

Found USDMF

22229
Active
GEMCITABINE HYDROCHLORIDE USP
2008-11-26
CEP/COS

Found CEP/COS

R0-CEP 2022-499 - Rev 00
Valid
Gemcitabine hydrochloride, GA proce...
2023-02-28
Japanese DMF

Found JDMF

230MF10173
Gemcitabine hydrochloride [D] at 7-...
2018-12-21
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Gemcitabine Hydrochloride (USP/Ph. ...
2022-09-16
Application Number
22229
230MF10173
Indian CDSCO WC-0041
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-08-08
Filing Details
GEMCITABINE HYDROCHLORIDE USP
Gemcitabine hydrochloride, GA proce...
Gemcitabine hydrochloride [D] at 7-...
Gemcitabine Hydrochloride (USP/Ph. ...
Issue/Submission Date
2008-11-26
2023-02-28
2018-12-21
2022-09-16
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USDMF

Found USDMF

17507
Active
IRBESARTAN (FORM A) PROCESS I
2004-07-02
CEP/COS

Found CEP/COS

CEP 2017-104 - Rev 04
Valid
Irbesartan
2024-03-25
Japanese DMF

Found JDMF

228MF10007
Irbesartan at 7-2-A2,Hetero Corpora...
2016-01-08
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Irbesartan (USP/Ph. Eur)
2022-09-16
Application Number
17507
228MF10007
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
IRBESARTAN (FORM A) PROCESS I
Irbesartan
Irbesartan at 7-2-A2,Hetero Corpora...
Irbesartan (USP/Ph. Eur)
Issue/Submission Date
2004-07-02
2024-03-25
2016-01-08
2022-09-16
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USDMF

Found USDMF

18252
Active
LAMIVUDINE USP (PROCESS I)
2005-04-07
CEP/COS

Found CEP/COS

R1-CEP 2013-168 - Rev 00
Valid
Lamivudine, LAN process
2018-11-05
Japanese DMF

Found JDMF

229MF10157
Lamivudine at 7-2-A2,Hetero Corpora...
2017-08-08
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Lamivudine (USP/Ph. Eur)
2022-09-16
Application Number
18252
229MF10157
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
LAMIVUDINE USP (PROCESS I)
Lamivudine, LAN process
Lamivudine at 7-2-A2,Hetero Corpora...
Lamivudine (USP/Ph. Eur)
Issue/Submission Date
2005-04-07
2018-11-05
2017-08-08
2022-09-16
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USDMF

Found USDMF

24886
Active
LETROZOLE USP
2011-04-25
CEP/COS

Found CEP/COS

R1-CEP 2012-145 - Rev 02
Valid
Letrozole
2023-02-22
Japanese DMF

Found JDMF

226MF10028
Letrozole at 7-2-A2,Hetero Corporat...
2014-02-05
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Letrozole (USP/Ph. Eur)
2022-09-16
Application Number
24886
226MF10028
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
LETROZOLE USP
Letrozole
Letrozole at 7-2-A2,Hetero Corporat...
Letrozole (USP/Ph. Eur)
Issue/Submission Date
2011-04-25
2023-02-22
2014-02-05
2022-09-16
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USDMF

Found USDMF

17738
Active
LEVETIRACETAM (FORM 1)
2004-10-07
CEP/COS

Found CEP/COS

R1-CEP 2014-113 - Rev 01
Valid
Levetiracetam, Form-I Process-II
2021-07-19
Japanese DMF

Found JDMF

302MF10091
Levetiracetam "K" at 7-2-A2,Hetero ...
2020-07-29
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Levetiracetam (USP/Ph. Eur)
2022-09-16
Application Number
17738
302MF10091
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
LEVETIRACETAM (FORM 1)
Levetiracetam, Form-I Process-II
Levetiracetam "K" at 7-2-A2,Hetero ...
Levetiracetam (USP/Ph. Eur)
Issue/Submission Date
2004-10-07
2021-07-19
2020-07-29
2022-09-16
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USDMF

Found USDMF

16510
Active
LISINOPRIL
2003-03-21
CEP/COS

Found CEP/COS

R0-CEP 2022-434 - Rev 00
Valid
Lisinopril dihydrate, Process-III
2023-05-04
Japanese DMF

Found JDMF

222MF10145
Lisinopril Hydrate at 7-2-A2, Heter...
2010-04-22
Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Lisinopril Dihydrate (USP/Ph. Eur.)
2022-07-04
Application Number
16510
222MF10145
Indian CDSCO WC-0040
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-03
Filing Details
LISINOPRIL
Lisinopril dihydrate, Process-III
Lisinopril Hydrate at 7-2-A2, Heter...
Lisinopril Dihydrate (USP/Ph. Eur.)
Issue/Submission Date
2003-03-21
2023-05-04
2010-04-22
2022-07-04
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USDMF

Found USDMF

19988
Active
LOSARTAN POTASSIUM (FORM 1)
2006-11-22
CEP/COS

Found CEP/COS

R1-CEP 2009-247 - Rev 08
Valid
Losartan potassium, Form I
2023-07-04
Japanese DMF

Found JDMF

303MF10096
Losartan potassium at 7-2-A2,Heter...
2021-06-22
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Losartan Potassium (Ph. Eur/USP)
2022-09-16
Application Number
19988
303MF10096
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
LOSARTAN POTASSIUM (FORM 1)
Losartan potassium, Form I
Losartan potassium at 7-2-A2,Heter...
Losartan Potassium (Ph. Eur/USP)
Issue/Submission Date
2006-11-22
2023-07-04
2021-06-22
2022-09-16
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USDMF

Found USDMF

26074
Active
MOXIFLOXACIN HYDROCHLORIDE
2012-05-22
CEP/COS

Found CEP/COS

CEP 2017-113 - Rev 01
Valid
Moxifloxacin hydrochloride
2023-11-27
Japanese DMF

Found JDMF

226MF10043
Moxifloxacin hydrochloride at 7-2-A...
2014-02-19
Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Moxifloxacin Hydrochloride (USP/Ph....
2022-07-04
Application Number
26074
226MF10043
Indian CDSCO WC-0040
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-03
Filing Details
MOXIFLOXACIN HYDROCHLORIDE
Moxifloxacin hydrochloride
Moxifloxacin hydrochloride at 7-2-A...
Moxifloxacin Hydrochloride (USP/Ph....
Issue/Submission Date
2012-05-22
2023-11-27
2014-02-19
2022-07-04
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USDMF

Found USDMF

20591
Active
OLANZAPINE (FORM-1)
2007-06-11
CEP/COS

Found CEP/COS

R0-CEP 2022-126 - Rev 00
Valid
Olanzapine, Form-I, Process II
2022-06-22
Japanese DMF

Found JDMF

227MF10065
Olanzapine at 7-2-A2, Hetero Corpor...
2015-03-06
Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Olanzapine (USP/Ph. Eur./IH)
2022-07-04
Application Number
20591
227MF10065
Indian CDSCO WC-0040
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-03
Filing Details
OLANZAPINE (FORM-1)
Olanzapine, Form-I, Process II
Olanzapine at 7-2-A2, Hetero Corpor...
Olanzapine (USP/Ph. Eur./IH)
Issue/Submission Date
2007-06-11
2022-06-22
2015-03-06
2022-07-04
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USDMF

Found USDMF

26992
Active
OLMESARTAN MEDOXOMIL
2013-03-20
CEP/COS

Found CEP/COS

R0-CEP 2017-305 - Rev 02
Valid
Olmesartan medoxomil
2022-12-12
Japanese DMF

Found JDMF

304MF10023
Olmesartan Medoxomil [D] at 7-2-A2,...
2022-01-26
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Olmesartan Medoxomil (IH/Ph. Eur)
2022-09-16
Application Number
26992
304MF10023
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
OLMESARTAN MEDOXOMIL
Olmesartan medoxomil
Olmesartan Medoxomil [D] at 7-2-A2,...
Olmesartan Medoxomil (IH/Ph. Eur)
Issue/Submission Date
2013-03-20
2022-12-12
2022-01-26
2022-09-16
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USDMF

Found USDMF

20845
Active
QUETIAPINE FUMARATE
2007-09-12
CEP/COS

Found CEP/COS

R1-CEP 2015-153 - Rev 02
Valid
Quetiapine Fumarate
2023-06-15
Japanese DMF

Found JDMF

228MF10094
Quetiapine fumarate at 7-2-A2,Heter...
2016-04-27
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Quetiapine Fumarate (IH)
2022-09-16
Application Number
20845
228MF10094
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
QUETIAPINE FUMARATE
Quetiapine Fumarate
Quetiapine fumarate at 7-2-A2,Heter...
Quetiapine Fumarate (IH)
Issue/Submission Date
2007-09-12
2023-06-15
2016-04-27
2022-09-16
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USDMF

Found USDMF

17987
Active
TERBINAFINE HYDROCHLORIDE
2005-01-12
CEP/COS

Found CEP/COS

R1-CEP 2012-310 - Rev 02
Valid
Terbinafine hydrochloride, Process ...
2020-10-20
Japanese DMF

Found JDMF

222MF10168
Terbinafine hydrochloride at 7-2-A2...
2010-06-08
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Terbenafine Hydrochloride (USP/Ph. ...
2022-09-16
Application Number
17987
222MF10168
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
TERBINAFINE HYDROCHLORIDE
Terbinafine hydrochloride, Process ...
Terbinafine hydrochloride at 7-2-A2...
Terbenafine Hydrochloride (USP/Ph. ...
Issue/Submission Date
2005-01-12
2020-10-20
2010-06-08
2022-09-16
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USDMF

Found USDMF

32138
Active
VORICONAZOLE (FORM-I)
2017-11-14
CEP/COS

Found CEP/COS

R0-CEP 2018-184 - Rev 01
Valid
Voriconazole, Form-I
2022-12-01
Japanese DMF

Found JDMF

305MF10027
Voriconazole at 7-2-A2,Hetero Corpo...
2023-02-08
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Voriconazole (IH/USP/BP/Ph.Eur )
2022-09-16
Application Number
32138
305MF10027
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
VORICONAZOLE (FORM-I)
Voriconazole, Form-I
Voriconazole at 7-2-A2,Hetero Corpo...
Voriconazole (IH/USP/BP/Ph.Eur )
Issue/Submission Date
2017-11-14
2022-12-01
2023-02-08
2022-09-16
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USDMF

Caution USDMF

16478
Inactive
AMLODIPINE BESILATE
2003-03-18
CEP/COS

Found CEP/COS

R1-CEP 2016-077 - Rev 00
Valid
Amlodipine besilate, Process II
2021-10-29
Japanese DMF

Found JDMF

223MF10106
Amlodipine besylate "F" at 7-2-A2, ...
2011-07-15
Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Amlodipine Besylate (Ph. Eur.)
2022-07-04
Application Number
16478
223MF10106
Indian CDSCO WC-0040
Status
Inactive
Fees Paid
N/A
Valid
 
Valid
2025-07-03
Filing Details
AMLODIPINE BESILATE
Amlodipine besilate, Process II
Amlodipine besylate "F" at 7-2-A2, ...
Amlodipine Besylate (Ph. Eur.)
Issue/Submission Date
2003-03-18
2021-10-29
2011-07-15
2022-07-04
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USDMF

Found USDMF

31455
Active
ARIPIPRAZOLE PROCESS-I
2017-03-04
CEP/COS

Found CEP/COS

R1-CEP 2013-361 - Rev 01
Valid
Aripiprazole, Type-I
2022-06-02
Japanese DMF

Found JDMF

228MF10005
Aripiprazole at 7-2-A2,Hetero Corpo...
2016-01-08
Written Confirmation

Caution WC

Indian CDSCO WC-0065
Expired
Aripiprazole ESP/EP
2019-08-16
Application Number
31455
228MF10005
Indian CDSCO WC-0065
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-15
Filing Details
ARIPIPRAZOLE PROCESS-I
Aripiprazole, Type-I
Aripiprazole at 7-2-A2,Hetero Corpo...
Aripiprazole ESP/EP
Issue/Submission Date
2017-03-04
2022-06-02
2016-01-08
2019-08-16
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USDMF

Found USDMF

24557
Active
CELECOXIB
2011-01-19
CEP/COS

Found CEP/COS

R1-CEP 2016-037 - Rev 01
Valid
Celecoxib
2023-02-22
Japanese DMF

Found JDMF

231MF10025
Celecoxib at 7-2-A2, Hetero Corpora...
2019-02-05
Written Confirmation

Caution WC

Indian CDSCO WC-0066
Expired
Celecoxib (IH/USP/Ph.Eur)
2019-08-09
Application Number
24557
231MF10025
Indian CDSCO WC-0066
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-08
Filing Details
CELECOXIB
Celecoxib
Celecoxib at 7-2-A2, Hetero Corpora...
Celecoxib (IH/USP/Ph.Eur)
Issue/Submission Date
2011-01-19
2023-02-22
2019-02-05
2019-08-09
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USDMF

Found USDMF

26185
Active
ESCITALOPRAM OXALATE (PROCESS II)
2012-06-28
CEP/COS

Found CEP/COS

CEP 2017-080 - Rev 06
Valid
Escitalopram oxalate, Process II
2023-10-27
Japanese DMF

Found JDMF

230MF10141
Escitalopram oxalate [D] at 7-2-A2,...
2018-10-12
Written Confirmation

Caution WC

Indian CDSCO WC-0041A4
Expired
Escitalopram Oxalate EP
2020-03-18
Application Number
26185
230MF10141
Indian CDSCO WC-0041A4
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-08
Filing Details
ESCITALOPRAM OXALATE (PROCESS II)
Escitalopram oxalate, Process II
Escitalopram oxalate [D] at 7-2-A2,...
Escitalopram Oxalate EP
Issue/Submission Date
2012-06-28
2023-10-27
2018-10-12
2020-03-18
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USDMF

Caution USDMF

23379
Inactive
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
2009-12-16
CEP/COS

Found CEP/COS

R1-CEP 2014-333 - Rev 01
Valid
Esomeprazole magnesium dihydrate
2023-03-07
Japanese DMF

Found JDMF

301MF10050
Esomeprazole Magnesium Hydrate "D" ...
2019-08-20
Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Esomeprazole Magnesium
2022-07-04
Application Number
23379
301MF10050
Indian CDSCO WC-0040
Status
Inactive
Fees Paid
N/A
Valid
 
Valid
2025-07-03
Filing Details
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Esomeprazole magnesium dihydrate
Esomeprazole Magnesium Hydrate "D" ...
Esomeprazole Magnesium
Issue/Submission Date
2009-12-16
2023-03-07
2019-08-20
2022-07-04
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USDMF

Caution USDMF

25116
Inactive
IMATINIB MESYLATE AMORPHOUS
2011-07-12
CEP/COS

Found CEP/COS

R0-CEP 2018-289 - Rev 01
Valid
Imatinib mesilate, Form-β
2020-01-23
Japanese DMF

Found JDMF

225MF10046
Imatinib mesylate at 7-2-A2,Hetero ...
2013-03-05
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Imatinib Mesylate(1H)
2022-09-16
Application Number
25116
225MF10046
Indian CDSCO WC-0041
Status
Inactive
Fees Paid
N/A
Valid
 
Valid
2025-08-08
Filing Details
IMATINIB MESYLATE AMORPHOUS
Imatinib mesilate, Form-β
Imatinib mesylate at 7-2-A2,Hetero ...
Imatinib Mesylate(1H)
Issue/Submission Date
2011-07-12
2020-01-23
2013-03-05
2022-09-16
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USDMF

Found USDMF

27354
Active
PREGABALIN
2013-07-29
CEP/COS

Found CEP/COS

CEP 2021-197 - Rev 01
Valid
Pregabalin, Process II
2023-10-24
Japanese DMF

Found JDMF

230MF10102
Pregabalin at 7-2-A2, Hetero Corpor...
2018-08-08
Written Confirmation

Caution WC

Indian CDSCO WC-0066
Expired
Pregabalin (IH)
2019-08-09
Application Number
27354
230MF10102
Indian CDSCO WC-0066
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-08
Filing Details
PREGABALIN
Pregabalin, Process II
Pregabalin at 7-2-A2, Hetero Corpor...
Pregabalin (IH)
Issue/Submission Date
2013-07-29
2023-10-24
2018-08-08
2019-08-09
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USDMF

Caution USDMF

15731
Inactive
SERTRALINE HCL USP (FORM II PROCESS...
2001-11-14
CEP/COS

Found CEP/COS

R1-CEP 2012-218 - Rev 04
Valid
Sertraline hydrochloride, Alternate...
2022-09-06
Japanese DMF

Found JDMF

226MF10175
Sertraline hydrochloride at 7-2-A2,...
2014-09-01
Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Sertraline Hydrochloride (USP/Ph. E...
2022-07-04
Application Number
15731
226MF10175
Indian CDSCO WC-0040
Status
Inactive
Fees Paid
N/A
Valid
 
Valid
2025-07-03
Filing Details
SERTRALINE HCL USP (FORM II PROCESS...
Sertraline hydrochloride, Alternate...
Sertraline hydrochloride at 7-2-A2,...
Sertraline Hydrochloride (USP/Ph. E...
Issue/Submission Date
2001-11-14
2022-09-06
2014-09-01
2022-07-04
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USDMF

Caution USDMF

24873
Inactive
VALSARTAN
2011-04-18
CEP/COS

Found CEP/COS

R0-CEP 2021-152 - Rev 01
Valid
Valsartan, VL Process
2022-12-01
Japanese DMF

Found JDMF

304MF10152
Valsartan “VQL” at 7-2-A2,Heter...
2022-12-07
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Valsartan (Ph. Eur/USP)
2022-09-16
Application Number
24873
304MF10152
Indian CDSCO WC-0041
Status
Inactive
Fees Paid
N/A
Valid
 
Valid
2025-08-08
Filing Details
VALSARTAN
Valsartan, VL Process
Valsartan “VQL” at 7-2-A2,Heter...
Valsartan (Ph. Eur/USP)
Issue/Submission Date
2011-04-18
2022-12-01
2022-12-07
2022-09-16
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USDMF

Found USDMF

18787
Active
AMLODIPINE BESYLATE
2005-09-19
CEP/COS

Found CEP/COS

R1-CEP 2006-003 - Rev 04
Valid
Amlodipine besilate
2018-04-12
Japanese DMF

Found JDMF

218MF10912
Amlodipine besylate at 7-2-A2, Hete...
2006-11-10
Written Confirmation

Close WC

Application Number
18787
218MF10912
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
AMLODIPINE BESYLATE
Amlodipine besilate
Amlodipine besylate at 7-2-A2, Hete...
Issue/Submission Date
2005-09-19
2018-04-12
2006-11-10
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USDMF

Found USDMF

17979
Active
CITALOPRAM HYDROBROMIDE (PROCESS I)
2005-01-12
CEP/COS

Found CEP/COS

R1-CEP 2012-120 - Rev 03
Valid
Citalopram hydrobromide, CTP Proces...
2021-11-17
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Citalopram Hydrobromide (Ph. Eur./U...
2022-07-04
Application Number
17979
Indian CDSCO WC-0040
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-03
Filing Details
CITALOPRAM HYDROBROMIDE (PROCESS I)
Citalopram hydrobromide, CTP Proces...
Citalopram Hydrobromide (Ph. Eur./U...
Issue/Submission Date
2005-01-12
2021-11-17
2022-07-04
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USDMF

Found USDMF

16008
Active
FOSINOPRIL SODIUM
2002-06-11
CEP/COS

Found CEP/COS

CEP 2013-018 - Rev 02
Valid
Fosinopril sodium
2023-11-29
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Fosinopril Sodium (USP/Ph Eur)
2022-07-04
Application Number
16008
Indian CDSCO WC-0040
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-03
Filing Details
FOSINOPRIL SODIUM
Fosinopril sodium
Fosinopril Sodium (USP/Ph Eur)
Issue/Submission Date
2002-06-11
2023-11-29
2022-07-04
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USDMF

Found USDMF

17656
Active
GLIMEPIRIDE
2004-09-09
CEP/COS

Found CEP/COS

R1-CEP 2007-156 - Rev 04
Valid
Glimepiride
2019-02-27
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Glimepiride (USP/Ph. Eur.)
2022-07-04
Application Number
17656
Indian CDSCO WC-0040
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-03
Filing Details
GLIMEPIRIDE
Glimepiride
Glimepiride (USP/Ph. Eur.)
Issue/Submission Date
2004-09-09
2019-02-27
2022-07-04
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USDMF

Found USDMF

19852
Active
LOPINAVIR USP
2006-10-10
CEP/COS

Found CEP/COS

R0-CEP 2020-396 - Rev 00
Valid
Lopinavir
2022-10-28
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Lopinavir (USP/IH/Ph. Eur)
2022-09-16
Application Number
19852
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
LOPINAVIR USP
Lopinavir
Lopinavir (USP/IH/Ph. Eur)
Issue/Submission Date
2006-10-10
2022-10-28
2022-09-16
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USDMF

Found USDMF

17782
Active
NEVIRAPINE
2004-10-26
CEP/COS

Found CEP/COS

R1-CEP 2016-076 - Rev 00
Valid
Nevirapine, Additional site
2021-09-08
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Nevirapine (Ph. Eur/USP)
2022-09-16
Application Number
17782
Indian CDSCO WC-0041
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-08-08
Filing Details
NEVIRAPINE
Nevirapine, Additional site
Nevirapine (Ph. Eur/USP)
Issue/Submission Date
2004-10-26
2021-09-08
2022-09-16
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USDMF

Found USDMF

15024
Active
OMEPRAZOLE
2000-08-25
CEP/COS

Found CEP/COS

CEP 2015-011 - Rev 01
Valid
Omeprazole, Form-B
2023-11-08
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Omeprazole USP/EP
2022-07-04
Application Number
15024
Indian CDSCO WC-0040
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-03
Filing Details
OMEPRAZOLE
Omeprazole, Form-B
Omeprazole USP/EP
Issue/Submission Date
2000-08-25
2023-11-08
2022-07-04
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USDMF

Found USDMF

20271
Active
PANTOPRAZOLE SODIUM SESQUIHYDRATE
2007-02-13
CEP/COS

Found CEP/COS

R1-CEP 2008-289 - Rev 03
Valid
Pantoprazole sodium sesquihydrate
2021-04-21
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Pantoprazole Sodium Sesquihydrate (...
2022-07-04
Application Number
20271
Indian CDSCO WC-0040
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-03
Filing Details
PANTOPRAZOLE SODIUM SESQUIHYDRATE
Pantoprazole sodium sesquihydrate
Pantoprazole Sodium Sesquihydrate (...
Issue/Submission Date
2007-02-13
2021-04-21
2022-07-04
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USDMF

Found USDMF

19095
Active
PERINDOPRIL TERT-BUTYLAMINE
2006-01-06
CEP/COS

Found CEP/COS

R1-CEP 2010-118 - Rev 04
Valid
Perindopril tert-butylamine
2021-07-27
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Perindopril tert-Butylamine (USP/Ph...
2022-07-04
Application Number
19095
Indian CDSCO WC-0040
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-03
Filing Details
PERINDOPRIL TERT-BUTYLAMINE
Perindopril tert-butylamine
Perindopril tert-Butylamine (USP/Ph...
Issue/Submission Date
2006-01-06
2021-07-27
2022-07-04
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USDMF

Found USDMF

19853
Active
PRAMIPEXOLE DIHYDROCHLORIDE
2006-10-10
CEP/COS

Found CEP/COS

R1-CEP 2010-328 - Rev 03
Valid
Pramipexole dihydrochloride monohyd...
2023-02-17
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Pramipexole Dihydrochloride (USP/Ph...
2022-07-04
Application Number
19853
Indian CDSCO WC-0040
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-03
Filing Details
PRAMIPEXOLE DIHYDROCHLORIDE
Pramipexole dihydrochloride monohyd...
Pramipexole Dihydrochloride (USP/Ph...
Issue/Submission Date
2006-10-10
2023-02-17
2022-07-04
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USDMF

Found USDMF

18338
Active
RAMIPRIL
2004-05-09
CEP/COS

Found CEP/COS

R1-CEP 2006-147 - Rev 05
Valid
Ramipril
2019-09-05
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Ramipril (USP/Ph. Eur)
2022-09-16
Application Number
18338
Indian CDSCO WC-0041
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-08-08
Filing Details
RAMIPRIL
Ramipril
Ramipril (USP/Ph. Eur)
Issue/Submission Date
2004-05-09
2019-09-05
2022-09-16
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USDMF

Found USDMF

18346
Active
TOPIRAMATE
2005-05-12
CEP/COS

Found CEP/COS

R0-CEP 2020-130 - Rev 01
Valid
Topiramate
2023-03-06
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0040
Valid
Topiramate (IH/USP)
2022-07-04
Application Number
18346
Indian CDSCO WC-0040
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-03
Filing Details
TOPIRAMATE
Topiramate
Topiramate (IH/USP)
Issue/Submission Date
2005-05-12
2023-03-06
2022-07-04
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USDMF

Found USDMF

18360
Active
TORSEMIDE
2007-06-26
CEP/COS

Found CEP/COS

R0-CEP 2019-255 - Rev 01
Valid
Torasemide
2023-02-08
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Torsemide Anhydrous (Ph. Eur)
2022-09-16
Application Number
18360
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
TORSEMIDE
Torasemide
Torsemide Anhydrous (Ph. Eur)
Issue/Submission Date
2007-06-26
2023-02-08
2022-09-16
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USDMF

Found USDMF

18291
Active
ZIDOVUDINE (PROCESS I)
2005-04-20
CEP/COS

Found CEP/COS

R1-CEP 2008-333 - Rev 05
Valid
Zidovudine
2022-12-07
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Zidovudine (USP/Ph. Eur)
2022-09-16
Application Number
18291
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
ZIDOVUDINE (PROCESS I)
Zidovudine
Zidovudine (USP/Ph. Eur)
Issue/Submission Date
2005-04-20
2022-12-07
2022-09-16
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USDMF

Found USDMF

18488
Active
ZONISAMIDE
2005-07-07
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

305MF10021
Zonisamide at 7-2-A2,Hetero Corpora...
2023-02-08
Written Confirmation

Found WC

Indian CDSCO WC-0041
Valid
Zonisamide (IH/USP)
2022-09-16
Application Number
18488
305MF10021
Indian CDSCO WC-0041
Status
Active
Fees Paid
N/A
 
Valid
2025-08-08
Filing Details
ZONISAMIDE
Zonisamide at 7-2-A2,Hetero Corpora...
Zonisamide (IH/USP)
Issue/Submission Date
2005-07-07
2023-02-08
2022-09-16
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PHARMACOMPASS
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