Athena Athena

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

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Unichem Laboratories Limited
india-flag Flag
Country
Country
India
Address
Address
Unichem Bhavan Prabhat Estate, Off S.V.Road, Jogeshwari (West), Mumbai - 400 102
Telephone
Telephone
+ 91-022-66-888-333
Twitter
Twitter

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USDMF

Found USDMF

16509
Active
AMLODIPINE BESILATE USP
2003-04-01
CEP/COS

Found CEP/COS

R1-CEP 2002-184 - Rev 07
Valid
Amlodipine besilate
2022-06-21
Japanese DMF

Found JDMF

231MF10060
Amlodipine besilate at Unichem Bhav...
2019-02-26
Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Amlodipine Besylate (Ph. Eur.)
2019-07-29
Application Number
16509
231MF10060
Indian CDSCO WC-0063
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-28
Filing Details
AMLODIPINE BESILATE USP
Amlodipine besilate
Amlodipine besilate at Unichem Bhav...
Amlodipine Besylate (Ph. Eur.)
Issue/Submission Date
2003-04-01
2022-06-21
2019-02-26
2019-07-29
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USDMF

Found USDMF

16189
Active
MELOXICAM USP
2002-10-04
CEP/COS

Found CEP/COS

R1-CEP 2009-039 - Rev 01
Valid
Meloxicam
2016-07-22
Japanese DMF

Found JDMF

219MF10088
Meloxicam at Unichem Bhavan, Prabha...
2007-03-14
Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Meloxicam (Ph. Fur.)
2019-07-29
Application Number
16189
219MF10088
Indian CDSCO WC-0063
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-28
Filing Details
MELOXICAM USP
Meloxicam
Meloxicam at Unichem Bhavan, Prabha...
Meloxicam (Ph. Fur.)
Issue/Submission Date
2002-10-04
2016-07-22
2007-03-14
2019-07-29
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USDMF

Caution USDMF

6237
Inactive
HYDROCHLOROTHIAZIDE B.P.
1985-06-10
CEP/COS

Found CEP/COS

CEP 2000-091 - Rev 06
Valid
Hydrochlorothiazide
2023-09-12
Japanese DMF

Found JDMF

225MF10021
Japanese Pharmacopoeia hydrochlorot...
2013-02-06
Written Confirmation

Caution WC

Indian CDSCO WC-0468
Expired
Hydrochlorthiazide EP/USP
2020-03-31
Application Number
6237
225MF10021
Indian CDSCO WC-0468
Status
Inactive
Fees Paid
N/A
Valid
 
Expired
2023-03-30
Filing Details
HYDROCHLOROTHIAZIDE B.P.
Hydrochlorothiazide
Japanese Pharmacopoeia hydrochlorot...
Hydrochlorthiazide EP/USP
Issue/Submission Date
1985-06-10
2023-09-12
2013-02-06
2020-03-31
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USDMF

Found USDMF

22638
Active
ALFUZOSIN HYDROCHLORIDE USP
2009-03-30
CEP/COS

Found CEP/COS

R1-CEP 2008-294 - Rev 00
Valid
Alfuzosin hydrochloride
2015-09-16
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Alfuzosin HCL (Ph. Eur.)
2019-07-22
Application Number
22638
Indian CDSCO WC-0062
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-21
Filing Details
ALFUZOSIN HYDROCHLORIDE USP
Alfuzosin hydrochloride
Alfuzosin HCL (Ph. Eur.)
Issue/Submission Date
2009-03-30
2015-09-16
2019-07-22
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USDMF

Found USDMF

24098
Active
ARIPIPRAZOLE USP
2010-09-02
CEP/COS

Found CEP/COS

R1-CEP 2015-010 - Rev 00
Valid
Aripiprazole
2021-09-23
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Aripriprazole (EP)
2019-07-29
Application Number
24098
Indian CDSCO WC-0063
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-28
Filing Details
ARIPIPRAZOLE USP
Aripiprazole
Aripriprazole (EP)
Issue/Submission Date
2010-09-02
2021-09-23
2019-07-29
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USDMF

Found USDMF

15847
Active
BENDROFLUMETHIAZIDE USP
2002-02-04
CEP/COS

Found CEP/COS

R1-CEP 2002-102 - Rev 01
Valid
Bendroflumethiazide
2009-03-23
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Bendroflumethiazide (Ph. Eur.)
2019-07-29
Application Number
15847
Indian CDSCO WC-0063
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-28
Filing Details
BENDROFLUMETHIAZIDE USP
Bendroflumethiazide
Bendroflumethiazide (Ph. Eur.)
Issue/Submission Date
2002-02-04
2009-03-23
2019-07-29
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USDMF

Found USDMF

16398
Active
BISOPROLOL FUMARATE USP
2003-01-29
CEP/COS

Found CEP/COS

R1-CEP 2008-038 - Rev 00
Valid
Bisoprolol fumarate
2014-10-03
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Bisoprolol Fumarate (Ph. Eur.)
2019-07-29
Application Number
16398
Indian CDSCO WC-0063
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-28
Filing Details
BISOPROLOL FUMARATE USP
Bisoprolol fumarate
Bisoprolol Fumarate (Ph. Eur.)
Issue/Submission Date
2003-01-29
2014-10-03
2019-07-29
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USDMF

Found USDMF

29704
Active
BUSPIRONE HYDROCHLORIDE USP
2015-09-29
CEP/COS

Found CEP/COS

CEP 2022-151 - Rev 00
Valid
Buspirone hydrochloride
2023-12-06
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062A4
Expired
Buspirone Hydrochloride USP
2021-05-21
Application Number
29704
Indian CDSCO WC-0062A4
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-21
Filing Details
BUSPIRONE HYDROCHLORIDE USP
Buspirone hydrochloride
Buspirone Hydrochloride USP
Issue/Submission Date
2015-09-29
2023-12-06
2021-05-21
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USDMF

Found USDMF

16278
Active
HYDROCHLOROTHIAZIDE USP
2002-11-26
CEP/COS

Found CEP/COS

R0-CEP 2020-017 - Rev 00
Valid
Hydrochlorothiazide, Process 2
2020-04-28
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Hydrochlorthiazide (Ph. Eur.)
2019-07-29
Application Number
16278
Indian CDSCO WC-0063
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-28
Filing Details
HYDROCHLOROTHIAZIDE USP
Hydrochlorothiazide, Process 2
Hydrochlorthiazide (Ph. Eur.)
Issue/Submission Date
2002-11-26
2020-04-28
2019-07-29
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USDMF

Found USDMF

23835
Active
IRBESARTAN USP
2010-06-04
CEP/COS

Found CEP/COS

R1-CEP 2011-151 - Rev 02
Valid
Irbesartan
2022-03-01
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062A3
Expired
Irbesartan EP
2019-10-03
Application Number
23835
Indian CDSCO WC-0062A3
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-21
Filing Details
IRBESARTAN USP
Irbesartan
Irbesartan EP
Issue/Submission Date
2010-06-04
2022-03-01
2019-10-03
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USDMF

Found USDMF

20835
Active
LAMOTRIGINE USP API
2007-09-10
CEP/COS

Found CEP/COS

R1-CEP 2009-376 - Rev 00
Valid
Lamotrigine
2016-02-05
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Lamotrigine EP
2019-07-22
Application Number
20835
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-21
Filing Details
LAMOTRIGINE USP API
Lamotrigine
Lamotrigine EP
Issue/Submission Date
2007-09-10
2016-02-05
2019-07-22
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USDMF

Found USDMF

21484
Active
NATEGLINIDE
2008-03-25
CEP/COS

Found CEP/COS

R1-CEP 2015-134 - Rev 00
Valid
Nateglinide, Form H
2021-12-17
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Nateglinide IH/EP
2019-07-22
Application Number
21484
Indian CDSCO WC-0062
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-21
Filing Details
NATEGLINIDE
Nateglinide, Form H
Nateglinide IH/EP
Issue/Submission Date
2008-03-25
2021-12-17
2019-07-22
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USDMF

Found USDMF

32438
Active
PHENYLEPHRINE HYDROCHLORIDE USP
2018-01-24
CEP/COS

Found CEP/COS

R0-CEP 2018-053 - Rev 00
Valid
Phenylephrine hydrochloride
2019-04-05
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Phenylephrine Hydrochloride EP
2019-07-22
Application Number
32438
Indian CDSCO WC-0062
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-21
Filing Details
PHENYLEPHRINE HYDROCHLORIDE USP
Phenylephrine hydrochloride
Phenylephrine Hydrochloride EP
Issue/Submission Date
2018-01-24
2019-04-05
2019-07-22
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USDMF

Found USDMF

28060
Active
PIROXICAM USP
2014-03-28
CEP/COS

Found CEP/COS

R1-CEP 2014-289 - Rev 00
Valid
Piroxicam
2021-02-25
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Piroxicam (IP/EP/EP/USP)
2019-07-29
Application Number
28060
Indian CDSCO WC-0063
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-28
Filing Details
PIROXICAM USP
Piroxicam
Piroxicam (IP/EP/EP/USP)
Issue/Submission Date
2014-03-28
2021-02-25
2019-07-29
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USDMF

Found USDMF

25907
Active
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
2012-03-30
CEP/COS

Found CEP/COS

R1-CEP 2012-193 - Rev 00
Valid
Pramipexole dihydrochloride monohyd...
2019-01-11
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Pramipexole Dihydrochloride Monohyd...
2019-07-29
Application Number
25907
Indian CDSCO WC-0063
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-28
Filing Details
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYD...
Pramipexole dihydrochloride monohyd...
Pramipexole Dihydrochloride Monohyd...
Issue/Submission Date
2012-03-30
2019-01-11
2019-07-29
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USDMF

Found USDMF

22888
Active
QUETIAPINE FUMARATE USP
2009-07-01
CEP/COS

Found CEP/COS

R1-CEP 2015-137 - Rev 00
Valid
Quetiapine Fumarate
2022-10-18
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0468A1
Expired
Quetiapine Fumarate EP
2020-11-12
Application Number
22888
Indian CDSCO WC-0468A1
Status
Active
Fees Paid
N/A
Valid
 
Expired
2023-03-30
Filing Details
QUETIAPINE FUMARATE USP
Quetiapine Fumarate
Quetiapine Fumarate EP
Issue/Submission Date
2009-07-01
2022-10-18
2020-11-12
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USDMF

Found USDMF

27991
Active
RIZATRIPTAN BENZOATE USP
2014-03-11
CEP/COS

Found CEP/COS

R1-CEP 2014-290 - Rev 00
Valid
Rizatriptan benzoate
2021-09-16
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Rizatriptan Benzoate (IP/EP/USP)
2019-07-29
Application Number
27991
Indian CDSCO WC-0063
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-28
Filing Details
RIZATRIPTAN BENZOATE USP
Rizatriptan benzoate
Rizatriptan Benzoate (IP/EP/USP)
Issue/Submission Date
2014-03-11
2021-09-16
2019-07-29
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USDMF

Found USDMF

30383
Active
SOLIFENACIN SUCCINATE
2016-03-29
CEP/COS

Found CEP/COS

R1-CEP 2017-083 - Rev 00
Valid
Solifenacin succinate
2023-03-31
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063A3
Expired
Solifenacin Succinate Ph.E ur
2020-02-14
Application Number
30383
Indian CDSCO WC-0063A3
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-28
Filing Details
SOLIFENACIN SUCCINATE
Solifenacin succinate
Solifenacin Succinate Ph.E ur
Issue/Submission Date
2016-03-29
2023-03-31
2020-02-14
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USDMF

Found USDMF

29027
Active
TADALAFIL USP
2015-02-03
CEP/COS

Found CEP/COS

R1-CEP 2015-132 - Rev 00
Valid
Tadalafil
2021-07-07
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Tadalafil USP/BP/EP
2019-07-29
Application Number
29027
Indian CDSCO WC-0063
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-28
Filing Details
TADALAFIL USP
Tadalafil
Tadalafil USP/BP/EP
Issue/Submission Date
2015-02-03
2021-07-07
2019-07-29
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USDMF

Found USDMF

24374
Active
TAMSULOSIN HYDROCHLORIDE USP
2010-12-01
CEP/COS

Found CEP/COS

R1-CEP 2011-381 - Rev 00
Valid
Tamsulosin hydrochloride
2019-10-23
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Tamsulosin Hydrochloride (Ph. Eur.)
2019-07-29
Application Number
24374
Indian CDSCO WC-0063
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-28
Filing Details
TAMSULOSIN HYDROCHLORIDE USP
Tamsulosin hydrochloride
Tamsulosin Hydrochloride (Ph. Eur.)
Issue/Submission Date
2010-12-01
2019-10-23
2019-07-29
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USDMF

Found USDMF

29705
Active
TERIFLUNOMIDE
2015-09-29
CEP/COS

Found CEP/COS

R0-CEP 2023-080 - Rev 00
Valid
Teriflunomide
2023-05-31
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Teriflunomide IH
2019-07-29
Application Number
29705
Indian CDSCO WC-0063
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-28
Filing Details
TERIFLUNOMIDE
Teriflunomide
Teriflunomide IH
Issue/Submission Date
2015-09-29
2023-05-31
2019-07-29
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USDMF

Found USDMF

21193
Active
ZOLPIDEM TARTRATE USP
2007-12-28
CEP/COS

Found CEP/COS

R1-CEP 2008-153 - Rev 00
Valid
Zolpidem tartrate
2015-01-23
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Zolpidem Tartrate (Ph. Eur.)
2019-07-22
Application Number
21193
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-21
Filing Details
ZOLPIDEM TARTRATE USP
Zolpidem tartrate
Zolpidem Tartrate (Ph. Eur.)
Issue/Submission Date
2007-12-28
2015-01-23
2019-07-22
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USDMF

Caution USDMF

7923
Inactive
BUPRENORPHINE HYDROCHLORIDE
1989-01-23
CEP/COS

Found CEP/COS

R1-CEP 2009-223 - Rev 00
Valid
Buprenorphine hydrochloride
2016-11-10
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Buprenorphine Hydrochloride (Ph. Eu...
2019-07-29
Application Number
7923
Indian CDSCO WC-0063
Status
Inactive
Fees Paid
N/A
Valid
 
Expired
2022-07-28
Filing Details
BUPRENORPHINE HYDROCHLORIDE
Buprenorphine hydrochloride
Buprenorphine Hydrochloride (Ph. Eu...
Issue/Submission Date
1989-01-23
2016-11-10
2019-07-29
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USDMF

Found USDMF

32037
Active
CHLORTHALIDONE USP
2017-09-21
CEP/COS

Found CEP/COS

R0-CEP 2019-088 - Rev 00
Valid
Chlortalidone
2020-05-14
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
32037
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CHLORTHALIDONE USP
Chlortalidone
Issue/Submission Date
2017-09-21
2020-05-14
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USDMF

Caution USDMF

6357
Inactive
CLONIDINE HYDROCHLORIDE
1986-05-12
CEP/COS

Found CEP/COS

R1-CEP 2004-072 - Rev 00
Valid
Clonidine hydrochloride
2015-03-03
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Clonidine Hydrochloride (Ph. Eur.)
2019-07-29
Application Number
6357
Indian CDSCO WC-0063
Status
Inactive
Fees Paid
N/A
Valid
 
Expired
2022-07-28
Filing Details
CLONIDINE HYDROCHLORIDE
Clonidine hydrochloride
Clonidine Hydrochloride (Ph. Eur.)
Issue/Submission Date
1986-05-12
2015-03-03
2019-07-29
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USDMF

Found USDMF

28474
Active
GLIPIZIDE USP
2014-09-16
CEP/COS

Caution CEP/COS

R0-CEP 2015-107 - Rev 01
Withdrawn by Holder
Glipizide
2019-04-12
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Glipizide (Ph.Eur.)
2019-07-22
Application Number
28474
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
Withdrawn by Holder
 
Expired
2022-07-21
Filing Details
GLIPIZIDE USP
Glipizide
Glipizide (Ph.Eur.)
Issue/Submission Date
2014-09-16
2019-04-12
2019-07-22
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USDMF

Found USDMF

22556
Active
LOSARTAN POTASSIUM USP
2009-03-13
CEP/COS

Caution CEP/COS

R1-CEP 2010-152 - Rev 02
Withdrawn by Holder
Losartan potassium
2019-10-11
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062A3
Expired
Losartan Potassium EP
2019-10-03
Application Number
22556
Indian CDSCO WC-0062A3
Status
Active
Fees Paid
N/A
Withdrawn by Holder
 
Expired
2022-07-21
Filing Details
LOSARTAN POTASSIUM USP
Losartan potassium
Losartan Potassium EP
Issue/Submission Date
2009-03-13
2019-10-11
2019-10-03
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USDMF

Caution USDMF

5783
Inactive
METRONIDAZOLE USP
1985-03-22
CEP/COS

Found CEP/COS

R1-CEP 2001-450 - Rev 07
Valid
Metronidazole
2022-11-16
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Metronidazole (Ph. Eur.)
2019-07-29
Application Number
5783
Indian CDSCO WC-0063
Status
Inactive
Fees Paid
N/A
Valid
 
Expired
2022-07-28
Filing Details
METRONIDAZOLE USP
Metronidazole
Metronidazole (Ph. Eur.)
Issue/Submission Date
1985-03-22
2022-11-16
2019-07-29
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USDMF

Found USDMF

32621
Active
TELMISARTAN USP
2018-03-22
CEP/COS

Caution CEP/COS

R0-CEP 2018-050 - Rev 00
Withdrawn by Holder
Telmisartan
2019-02-27
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Telmisartan (Ph. Eur.)
2019-07-22
Application Number
32621
Indian CDSCO WC-0062
Status
Active
Fees Paid
N/A
Withdrawn by Holder
 
Expired
2022-07-21
Filing Details
TELMISARTAN USP
Telmisartan
Telmisartan (Ph. Eur.)
Issue/Submission Date
2018-03-22
2019-02-27
2019-07-22
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USDMF

Found USDMF

32429
Active
ALLOPURINOL USP
2018-01-22
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Allopurinol USP
2019-07-22
Application Number
32429
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
ALLOPURINOL USP
Allopurinol USP
Issue/Submission Date
2018-01-22
2019-07-22
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USDMF

Found USDMF

33164
Active
ATOMOXETINE HYDROCHLORIDE USP
2018-09-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Atomoxetine Hydrochloride USP
2019-07-22
Application Number
33164
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
ATOMOXETINE HYDROCHLORIDE USP
Atomoxetine Hydrochloride USP
Issue/Submission Date
2018-09-28
2019-07-22
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USDMF

Found USDMF

25051
Active
BRIMONIDINE TARTRATE
2011-07-05
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Brimonidine Tartrate (IH)
2019-07-29
Application Number
25051
Indian CDSCO WC-0063
Status
Active
Fees Paid
N/A
 
Expired
2022-07-28
Filing Details
BRIMONIDINE TARTRATE
Brimonidine Tartrate (IH)
Issue/Submission Date
2011-07-05
2019-07-29
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

CEP 2017-100 - Rev 02
Valid
Bumetanide
2024-02-01
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Bumetanide (Ph.Eur.)
2019-07-22
Application Number
Indian CDSCO WC-0062
Status
Valid
 
Expired
2022-07-21
Filing Details
Bumetanide
Bumetanide (Ph.Eur.)
Issue/Submission Date
2024-02-01
2019-07-22
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USDMF

Found USDMF

30385
Active
CINACALCET HYDROCHLORIDE
2016-03-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Cinacalcet Hydrochloride IH
2019-07-22
Application Number
30385
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
CINACALCET HYDROCHLORIDE
Cinacalcet Hydrochloride IH
Issue/Submission Date
2016-03-31
2019-07-22
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USDMF

Found USDMF

23834
Active
EPROSARTAN MESYLATE
2010-06-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Eprosartan Mesylate
2019-07-22
Application Number
23834
Indian CDSCO WC-0062
Status
Active
Fees Paid
N/A
 
Expired
2022-07-21
Filing Details
EPROSARTAN MESYLATE
Eprosartan Mesylate
Issue/Submission Date
2010-06-03
2019-07-22
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USDMF

Found USDMF

24393
Active
FENOFIBRATE USP
2010-12-10
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Fenofibrate (Ph. Eur.)
2019-07-29
Application Number
24393
Indian CDSCO WC-0063
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-28
Filing Details
FENOFIBRATE USP
Fenofibrate (Ph. Eur.)
Issue/Submission Date
2010-12-10
2019-07-29
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USDMF

Found USDMF

24373
Active
LACIDIPINE BP
2010-12-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Lacidipine (BP)
2019-07-29
Application Number
24373
Indian CDSCO WC-0063
Status
Active
Fees Paid
N/A
 
Expired
2022-07-28
Filing Details
LACIDIPINE BP
Lacidipine (BP)
Issue/Submission Date
2010-12-01
2019-07-29
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USDMF

Found USDMF

32430
Active
LACOSAMIDE
2018-03-07
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Lacosamide IH
2019-07-22
Application Number
32430
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
LACOSAMIDE
Lacosamide IH
Issue/Submission Date
2018-03-07
2019-07-22
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USDMF

Found USDMF

22886
Active
MEMANTINE HYDROCHLORIDE USP
2009-06-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Memantine Hydrochloride IH
2019-07-22
Application Number
22886
Indian CDSCO WC-0062
Status
Active
Fees Paid
N/A
 
Expired
2022-07-21
Filing Details
MEMANTINE HYDROCHLORIDE USP
Memantine Hydrochloride IH
Issue/Submission Date
2009-06-30
2019-07-22
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USDMF

Found USDMF

32525
Active
METOPROLOL SUCCINATE USP
2018-03-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Metoprolol Succinate USP
2019-07-22
Application Number
32525
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
METOPROLOL SUCCINATE USP
Metoprolol Succinate USP
Issue/Submission Date
2018-03-29
2019-07-22
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USDMF

Found USDMF

31412
Active
MILNACIPRAN HYDROCHLORIDE
2017-02-15
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Milnacipran Hydrochloride IH
2019-07-22
Application Number
31412
Indian CDSCO WC-0062
Status
Active
Fees Paid
N/A
 
Expired
2022-07-21
Filing Details
MILNACIPRAN HYDROCHLORIDE
Milnacipran Hydrochloride IH
Issue/Submission Date
2017-02-15
2019-07-22
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USDMF

Found USDMF

33163
Active
MONTELUKAST SODIUM USP
2018-09-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Montelukast Sodium USP
2019-07-22
Application Number
33163
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
MONTELUKAST SODIUM USP
Montelukast Sodium USP
Issue/Submission Date
2018-09-28
2019-07-22
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USDMF

Caution USDMF

29026
Inactive
OLMESARTAN MEDOXOMIL USP
2015-02-04
CEP/COS

Caution CEP/COS

R0-CEP 2015-133 - Rev 00
Withdrawn by Holder
Olmesartan medoxomil
2017-04-06
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062A3
Expired
Olmesartan Medoxomil USP/EP
2019-10-03
Application Number
29026
Indian CDSCO WC-0062A3
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Expired
2022-07-21
Filing Details
OLMESARTAN MEDOXOMIL USP
Olmesartan medoxomil
Olmesartan Medoxomil USP/EP
Issue/Submission Date
2015-02-04
2017-04-06
2019-10-03
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USDMF

Found USDMF

32676
Active
PHENYTOIN SODIUM USP
2018-03-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Phenytoin Sodium USP
2019-07-22
Application Number
32676
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
PHENYTOIN SODIUM USP
Phenytoin Sodium USP
Issue/Submission Date
2018-03-29
2019-07-22
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USDMF

Found USDMF

28860
Active
PRASUGREL HYDROCHLORIDE USP
2015-01-07
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Prasugrel Hydrochloride (IH)
2019-07-29
Application Number
28860
Indian CDSCO WC-0063
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-28
Filing Details
PRASUGREL HYDROCHLORIDE USP
Prasugrel Hydrochloride (IH)
Issue/Submission Date
2015-01-07
2019-07-29
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USDMF

Found USDMF

35130
Active
QUETIAPINE FUMARATE (QPT PROCESS)
2020-08-26
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Quetiapine Hemifumarate
2019-07-22
Application Number
35130
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
QUETIAPINE FUMARATE (QPT PROCESS)
Quetiapine Hemifumarate
Issue/Submission Date
2020-08-26
2019-07-22
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USDMF

Found USDMF

27494
Active
RANOLAZINE
2013-09-25
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Ranolazine
2019-07-22
Application Number
27494
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
RANOLAZINE
Ranolazine
Issue/Submission Date
2013-09-25
2019-07-22
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USDMF

Found USDMF

15739
Active
TIZANIDINE HCL USP
2001-11-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0063
Expired
Tizanidine Hydrochloride (EP)
2019-07-29
Application Number
15739
Indian CDSCO WC-0063
Status
Active
Fees Paid
N/A
 
Expired
2022-07-28
Filing Details
TIZANIDINE HCL USP
Tizanidine Hydrochloride (EP)
Issue/Submission Date
2001-11-12
2019-07-29
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USDMF

Found USDMF

25155
Active
TOLTERODINE TARTRATE USP
2011-09-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0062
Expired
Tolterodine Tartrate USP
2019-07-22
Application Number
25155
Indian CDSCO WC-0062
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
TOLTERODINE TARTRATE USP
Tolterodine Tartrate USP
Issue/Submission Date
2011-09-29
2019-07-22
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USDMF

Found USDMF

28925
Active
WARFARIN SODIUM USP
2014-12-31
CEP/COS

Caution CEP/COS

R0-CEP 2015-059 - Rev 00
Withdrawn by Holder
Warfarin sodium
2016-12-02
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28925
Status
Active
Fees Paid
Reviewed
Withdrawn by Holder
 
Filing Details
WARFARIN SODIUM USP
Warfarin sodium
Issue/Submission Date
2014-12-31
2016-12-02
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