Athena Athena

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Mylan Inc

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Viatris
United_States_of_America Flag
Country
Country
U.S.A
Address
Address
Robert J. Coury Global Center 1000 Mylan Blvd. Canonsburg, PA 15317
Telephone
Telephone
+1.724.514.1800

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USDMF

Found USDMF

13277
Active
ACYCLOVIR USP
1998-10-22
CEP/COS

Found CEP/COS

R1-CEP 1998-029 - Rev 09
Valid
Aciclovir
2021-02-23
Japanese DMF

Found JDMF

218MF10974
Acyclovir at Plot No. 564/A/22, Roa...
2006-12-01
Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Aciclovir (Ph. Eur.)/USP
2022-06-22
Application Number
13277
218MF10974
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-28
Filing Details
ACYCLOVIR USP
Aciclovir
Acyclovir at Plot No. 564/A/22, Roa...
Aciclovir (Ph. Eur.)/USP
Issue/Submission Date
1998-10-22
2021-02-23
2006-12-01
2022-06-22
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USDMF

Found USDMF

17912
Active
IRBESARTAN USP
2004-12-20
CEP/COS

Found CEP/COS

R1-CEP 2010-124 - Rev 07
Valid
Irbesartan
2023-04-26
Japanese DMF

Found JDMF

228MF10138
Japanese Pharmacopoeia irbesartan a...
2016-07-27
Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Irbesartan USP/Ph.Eur
2022-06-22
Application Number
17912
228MF10138
Indian CDSCO WC-0117
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-28
Filing Details
IRBESARTAN USP
Irbesartan
Japanese Pharmacopoeia irbesartan a...
Irbesartan USP/Ph.Eur
Issue/Submission Date
2004-12-20
2023-04-26
2016-07-27
2022-06-22
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USDMF

Found USDMF

17739
Active
ITRACONAZOLE USP
2004-10-08
CEP/COS

Found CEP/COS

R1-CEP 2005-269 - Rev 05
Valid
Itraconazole
2022-09-16
Japanese DMF

Found JDMF

219MF10105
Itraconazole at Plot No. 564/A/22, ...
2007-03-23
Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Itraconazol USP/Ph.Eur
2022-06-22
Application Number
17739
219MF10105
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-28
Filing Details
ITRACONAZOLE USP
Itraconazole
Itraconazole at Plot No. 564/A/22, ...
Itraconazol USP/Ph.Eur
Issue/Submission Date
2004-10-08
2022-09-16
2007-03-23
2022-06-22
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USDMF

Found USDMF

19555
Active
LANSOPRAZOLE USP
2006-06-27
CEP/COS

Found CEP/COS

R1-CEP 2008-240 - Rev 02
Valid
Lansoprazole
2017-07-13
Japanese DMF

Found JDMF

227MF10198
Lansoprazole at Plot No. 564/A/22, ...
2015-08-06
Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Lansoprazole USP/EP
2022-06-22
Application Number
19555
227MF10198
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-28
Filing Details
LANSOPRAZOLE USP
Lansoprazole
Lansoprazole at Plot No. 564/A/22, ...
Lansoprazole USP/EP
Issue/Submission Date
2006-06-27
2017-07-13
2015-08-06
2022-06-22
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USDMF

Found USDMF

34226
Active
RIVAROXABAN USP
2019-10-15
CEP/COS

Found CEP/COS

CEP 2021-259 - Rev 01
Valid
Rivaroxaban, Modification-I
2023-12-18
Japanese DMF

Found JDMF

302MF10144
Rivaroxaban at Plot No. 564/A/22, R...
2020-12-07
Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Rivaroxaban EP
2022-06-22
Application Number
34226
302MF10144
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-28
Filing Details
RIVAROXABAN USP
Rivaroxaban, Modification-I
Rivaroxaban at Plot No. 564/A/22, R...
Rivaroxaban EP
Issue/Submission Date
2019-10-15
2023-12-18
2020-12-07
2022-06-22
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USDMF

Found USDMF

19098
Active
RIZATRIPTAN BENZOATE USP
2006-01-10
CEP/COS

Found CEP/COS

R1-CEP 2011-299 - Rev 02
Valid
Rizatriptan benzoate
2018-10-05
Japanese DMF

Found JDMF

227MF10282
Rizatriptan benzoate at Plot No. 56...
2015-12-15
Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Rizatriptan Benzoate (Ph.Eur.)
2022-06-22
Application Number
19098
227MF10282
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-28
Filing Details
RIZATRIPTAN BENZOATE USP
Rizatriptan benzoate
Rizatriptan benzoate at Plot No. 56...
Rizatriptan Benzoate (Ph.Eur.)
Issue/Submission Date
2006-01-10
2018-10-05
2015-12-15
2022-06-22
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USDMF

Found USDMF

17943
Active
VALACYCLOVIR HYDROCHLORIDE USP
2004-12-29
CEP/COS

Found CEP/COS

R1-CEP 2014-086 - Rev 02
Valid
Valaciclovir hydrochloride hydrate
2023-07-07
Japanese DMF

Found JDMF

224MF10156
Valaciclovir Hydrochloride Anhydrou...
2012-08-16
Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Valacyclovir Hydrochloride Anhydrou...
2022-06-22
Application Number
17943
224MF10156
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-28
Filing Details
VALACYCLOVIR HYDROCHLORIDE USP
Valaciclovir hydrochloride hydrate
Valaciclovir Hydrochloride Anhydrou...
Valacyclovir Hydrochloride Anhydrou...
Issue/Submission Date
2004-12-29
2023-07-07
2012-08-16
2022-06-22
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USDMF

Found USDMF

20402
Active
ALENDRONATE SODIUM USP (TRIHYDRATE)
2007-04-02
CEP/COS

Found CEP/COS

R1-CEP 2009-290 - Rev 01
Valid
Sodium alendronate trihydrate
2017-09-25
Japanese DMF

Found JDMF

220MF10178
Alendronate sodium hydrate at Plot ...
2008-07-31
Written Confirmation

Caution WC

Indian CDSCO WC-0015
Expired
Alendronate Sodium USP/Ph. Eur
2019-06-03
Application Number
20402
220MF10178
Indian CDSCO WC-0015
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-06-02
Filing Details
ALENDRONATE SODIUM USP (TRIHYDRATE)
Sodium alendronate trihydrate
Alendronate sodium hydrate at Plot ...
Alendronate Sodium USP/Ph. Eur
Issue/Submission Date
2007-04-02
2017-09-25
2008-07-31
2019-06-03
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USDMF

Found USDMF

16409
Active
ALLOPURINOL USP
2003-04-23
CEP/COS

Found CEP/COS

R1-CEP 2000-015 - Rev 06
Valid
Allopurinol
2017-09-19
Japanese DMF

Found JDMF

217MF10578
Allopurinol at Plot No. 564/A/22, R...
2005-09-14
Written Confirmation

Caution WC

Indian CDSCO WC-0015
Expired
Allopurinol USP/EP
2019-06-03
Application Number
16409
217MF10578
Indian CDSCO WC-0015
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-06-02
Filing Details
ALLOPURINOL USP
Allopurinol
Allopurinol at Plot No. 564/A/22, R...
Allopurinol USP/EP
Issue/Submission Date
2003-04-23
2017-09-19
2005-09-14
2019-06-03
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USDMF

Found USDMF

19861
Active
ATOMOXETINE HYDROCHLORIDE USP
2006-10-12
CEP/COS

Found CEP/COS

R1-CEP 2013-271 - Rev 01
Valid
Atomoxetine hydrochloride
2021-08-31
Japanese DMF

Found JDMF

229MF10128
Atomoxetine hydrochloride at Plot N...
2017-07-14
Written Confirmation

Caution WC

Indian CDSCO WC-0118
Expired
Atomoxetine Hydrochloride (Ph. Eur....
2019-08-05
Application Number
19861
229MF10128
Indian CDSCO WC-0118
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-04
Filing Details
ATOMOXETINE HYDROCHLORIDE USP
Atomoxetine hydrochloride
Atomoxetine hydrochloride at Plot N...
Atomoxetine Hydrochloride (Ph. Eur....
Issue/Submission Date
2006-10-12
2021-08-31
2017-07-14
2019-08-05
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USDMF

Caution USDMF

16708
Inactive
CLARITHROMYCIN USP (CXP)
2003-07-16
CEP/COS

Found CEP/COS

CEP 2005-266 - Rev 05
Valid
Clarithromycin
2023-11-23
Japanese DMF

Found JDMF

304MF10150
Clarithromycin at Plot No. 564/A/22...
2022-11-30
Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Clarithromycin USP/Ph.Eur
2022-06-22
Application Number
16708
304MF10150
Indian CDSCO WC-0117
Status
Inactive
Fees Paid
N/A
Valid
 
Valid
2025-07-28
Filing Details
CLARITHROMYCIN USP (CXP)
Clarithromycin
Clarithromycin at Plot No. 564/A/22...
Clarithromycin USP/Ph.Eur
Issue/Submission Date
2003-07-16
2023-11-23
2022-11-30
2022-06-22
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USDMF

Caution USDMF

17287
Inactive
LORATADINE USP (LDP)
2004-04-06
CEP/COS

Found CEP/COS

CEP 2007-171 - Rev 04
Valid
Loratadine
2024-03-07
Japanese DMF

Found JDMF

220MF10191
Loratadine at Plot No. 564/A/22, Ro...
2008-08-18
Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Loratadine (Ph. Fur.)
2022-06-22
Application Number
17287
220MF10191
Indian CDSCO WC-0117
Status
Inactive
Fees Paid
N/A
Valid
 
Valid
2025-07-28
Filing Details
LORATADINE USP (LDP)
Loratadine
Loratadine at Plot No. 564/A/22, Ro...
Loratadine (Ph. Fur.)
Issue/Submission Date
2004-04-06
2024-03-07
2008-08-18
2022-06-22
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USDMF

Found USDMF

20425
Active
MONTELUKAST SODIUM USP
2007-03-26
CEP/COS

Found CEP/COS

R1-CEP 2011-245 - Rev 01
Valid
Montelukast sodium
2021-09-01
Japanese DMF

Found JDMF

227MF10022
Montelukast sodium at Plot No. 564/...
2015-01-23
Written Confirmation

Caution WC

Indian CDSCO WC-0118
Expired
Montelukast Sodium (Ph. Eur.)
2019-08-05
Application Number
20425
227MF10022
Indian CDSCO WC-0118
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-04
Filing Details
MONTELUKAST SODIUM USP
Montelukast sodium
Montelukast sodium at Plot No. 564/...
Montelukast Sodium (Ph. Eur.)
Issue/Submission Date
2007-03-26
2021-09-01
2015-01-23
2019-08-05
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USDMF

Found USDMF

20417
Active
OLMESARTAN MEDOXOMIL USP
2007-03-23
CEP/COS

Found CEP/COS

R1-CEP 2012-043 - Rev 03
Valid
Olmesartan medoxomil
2021-09-01
Japanese DMF

Found JDMF

228MF10010
Olmesartan medoxomil at Plot No. 56...
2016-01-08
Written Confirmation

Caution WC

Indian CDSCO WC-0118
Expired
Olmesartan Medoxomil (Ph. Eur.)
2019-08-05
Application Number
20417
228MF10010
Indian CDSCO WC-0118
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-04
Filing Details
OLMESARTAN MEDOXOMIL USP
Olmesartan medoxomil
Olmesartan medoxomil at Plot No. 56...
Olmesartan Medoxomil (Ph. Eur.)
Issue/Submission Date
2007-03-23
2021-09-01
2016-01-08
2019-08-05
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USDMF

Found USDMF

17325
Active
SERTRALINE HYDROCHLORIDE USP (FORM ...
2004-04-20
CEP/COS

Found CEP/COS

R0-CEP 2023-151 - Rev 00
Valid
Sertraline hydrochloride, Process-I...
2023-07-12
Japanese DMF

Found JDMF

225MF10221
Sertraline hydrochloride at Plot No...
2013-12-03
Written Confirmation

Caution WC

Indian CDSCO WC-0016
Expired
Sertraline Hydrochloride Ph. Eur./U...
2019-06-26
Application Number
17325
225MF10221
Indian CDSCO WC-0016
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-06-25
Filing Details
SERTRALINE HYDROCHLORIDE USP (FORM ...
Sertraline hydrochloride, Process-I...
Sertraline hydrochloride at Plot No...
Sertraline Hydrochloride Ph. Eur./U...
Issue/Submission Date
2004-04-20
2023-07-12
2013-12-03
2019-06-26
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USDMF

Found USDMF

19097
Active
SILDENAFIL CITRATE USP
2006-01-10
CEP/COS

Found CEP/COS

R1-CEP 2012-317 - Rev 00
Valid
Sildenafil citrate
2019-07-12
Japanese DMF

Found JDMF

224MF10197
Sildenafil Citrate at Plot No. 564/...
2012-09-11
Written Confirmation

Caution WC

Indian CDSCO WC-0016
Expired
Sildenafil Citrate Ph.Eur
2019-06-26
Application Number
19097
224MF10197
Indian CDSCO WC-0016
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-06-25
Filing Details
SILDENAFIL CITRATE USP
Sildenafil citrate
Sildenafil Citrate at Plot No. 564/...
Sildenafil Citrate Ph.Eur
Issue/Submission Date
2006-01-10
2019-07-12
2012-09-11
2019-06-26
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USDMF

Found USDMF

21711
Active
SUMATRIPTAN SUCCINATE USP
2008-06-03
CEP/COS

Found CEP/COS

R1-CEP 2009-156 - Rev 02
Valid
Sumatriptan succinate
2021-08-31
Japanese DMF

Found JDMF

223MF10048
Sumatriptan succinate at Plot No. 5...
2011-04-06
Written Confirmation

Caution WC

Indian CDSCO WC-0118
Expired
Sumatriptan Succinate (Ph. Eur.)
2019-08-05
Application Number
21711
223MF10048
Indian CDSCO WC-0118
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-08-04
Filing Details
SUMATRIPTAN SUCCINATE USP
Sumatriptan succinate
Sumatriptan succinate at Plot No. 5...
Sumatriptan Succinate (Ph. Eur.)
Issue/Submission Date
2008-06-03
2021-08-31
2011-04-06
2019-08-05
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USDMF

Found USDMF

20640
Active
TADALAFIL USP
2007-06-15
CEP/COS

Found CEP/COS

R0-CEP 2019-201 - Rev 01
Valid
Tadalafil, Process II
2023-02-27
Japanese DMF

Found JDMF

230MF10148
Tadalafil at Plot No. 564/A/22, Roa...
2018-11-05
Written Confirmation

Caution WC

Indian CDSCO WC-0016A2
Expired
Tadalafil Ph. Eur
2020-03-20
Application Number
20640
230MF10148
Indian CDSCO WC-0016A2
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-26
Filing Details
TADALAFIL USP
Tadalafil, Process II
Tadalafil at Plot No. 564/A/22, Roa...
Tadalafil Ph. Eur
Issue/Submission Date
2007-06-15
2023-02-27
2018-11-05
2020-03-20
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USDMF

Found USDMF

18253
Active
VALSARTAN USP
2005-04-07
CEP/COS

Found CEP/COS

R1-CEP 2009-396 - Rev 06
Valid
Valsartan
2022-02-23
Japanese DMF

Found JDMF

226MF10153
Valsartan at Plot No. 564/A/22, Roa...
2014-09-01
Written Confirmation

Caution WC

Indian CDSCO WC-015
Expired
Valsartan USP/EP
2019-06-26
Application Number
18253
226MF10153
Indian CDSCO WC-015
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-03
Filing Details
VALSARTAN USP
Valsartan
Valsartan at Plot No. 564/A/22, Roa...
Valsartan USP/EP
Issue/Submission Date
2005-04-07
2022-02-23
2014-09-01
2019-06-26
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USDMF

Found USDMF

18221
Active
ZOLPIDEM TARTRATE USP
2005-03-30
CEP/COS

Found CEP/COS

R1-CEP 2006-293 - Rev 06
Valid
Zolpidem tartrate
2021-08-31
Japanese DMF

Found JDMF

230MF10139
Japanese Pharmacopoeia Zolpidem Tar...
2018-10-12
Written Confirmation

Caution WC

Indian CDSCO WC-0118
Expired
Zolpidem Tartrate (Ph. Eur.)
2019-08-05
Application Number
18221
230MF10139
Indian CDSCO WC-0118
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-08-04
Filing Details
ZOLPIDEM TARTRATE USP
Zolpidem tartrate
Japanese Pharmacopoeia Zolpidem Tar...
Zolpidem Tartrate (Ph. Eur.)
Issue/Submission Date
2005-03-30
2021-08-31
2018-10-12
2019-08-05
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USDMF

Found USDMF

18214
Active
ALPRAZOLAM USP
2005-03-30
CEP/COS

Found CEP/COS

R1-CEP 2008-060 - Rev 01
Valid
Alprazolam
2018-08-01
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Alprazolam (Ph. Eur.)
2022-06-22
Application Number
18214
Indian CDSCO WC-0117
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-28
Filing Details
ALPRAZOLAM USP
Alprazolam
Alprazolam (Ph. Eur.)
Issue/Submission Date
2005-03-30
2018-08-01
2022-06-22
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USDMF

Found USDMF

19554
Active
ARIPIPRAZOLE USP
2006-06-28
CEP/COS

Found CEP/COS

R1-CEP 2013-330 - Rev 01
Valid
Aripiprazole
2021-09-02
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Aripiprazole EP
2022-06-22
Application Number
19554
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-28
Filing Details
ARIPIPRAZOLE USP
Aripiprazole
Aripiprazole EP
Issue/Submission Date
2006-06-28
2021-09-02
2022-06-22
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USDMF

Found USDMF

20400
Active
CANDESARTAN CILEXETIL USP
2007-04-02
CEP/COS

Found CEP/COS

R1-CEP 2011-259 - Rev 05
Valid
Candesartan cilexetil
2022-06-22
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Candesartan Cilexetil EP
2022-06-22
Application Number
20400
Indian CDSCO WC-0117
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-28
Filing Details
CANDESARTAN CILEXETIL USP
Candesartan cilexetil
Candesartan Cilexetil EP
Issue/Submission Date
2007-04-02
2022-06-22
2022-06-22
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USDMF

Found USDMF

17741
Active
CETIRIZINE HYDROCHLORIDE USP
2004-10-08
CEP/COS

Found CEP/COS

R1-CEP 2000-031 - Rev 11
Valid
Cetirizine dihydrochloride
2022-03-09
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Cetirizine Hydrochloride USP
2022-06-22
Application Number
17741
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-28
Filing Details
CETIRIZINE HYDROCHLORIDE USP
Cetirizine dihydrochloride
Cetirizine Hydrochloride USP
Issue/Submission Date
2004-10-08
2022-03-09
2022-06-22
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USDMF

Found USDMF

21187
Active
DESLORATADINE USP
2007-12-21
CEP/COS

Found CEP/COS

R1-CEP 2013-319 - Rev 01
Valid
Desloratadine
2021-05-28
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Desloratadine (Ph. Eur)
2022-06-22
Application Number
21187
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-28
Filing Details
DESLORATADINE USP
Desloratadine
Desloratadine (Ph. Eur)
Issue/Submission Date
2007-12-21
2021-05-28
2022-06-22
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USDMF

Found USDMF

26657
Active
FEBUXOSTAT
2013-01-15
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

230MF10138
Febuxostat at Plot No. 564/A/22, Ro...
2018-10-01
Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Febuxostat IH
2022-06-22
Application Number
26657
230MF10138
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-28
Filing Details
FEBUXOSTAT
Febuxostat at Plot No. 564/A/22, Ro...
Febuxostat IH
Issue/Submission Date
2013-01-15
2018-10-01
2022-06-22
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USDMF

Found USDMF

15045
Active
FLUCONAZOLE USP
2000-08-11
CEP/COS

Found CEP/COS

R1-CEP 2007-256 - Rev 04
Valid
Fluconazole
2019-09-16
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Fluconazole USP/Ph.Eur
2022-06-22
Application Number
15045
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-28
Filing Details
FLUCONAZOLE USP
Fluconazole
Fluconazole USP/Ph.Eur
Issue/Submission Date
2000-08-11
2019-09-16
2022-06-22
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USDMF

Found USDMF

17750
Active
LAMIVUDINE USP
2004-10-08
CEP/COS

Found CEP/COS

R1-CEP 2014-034 - Rev 02
Valid
Lamivudine, SVL Process
2022-08-30
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0189n
Valid
Lamivudine EP
2022-06-08
Application Number
17750
Indian CDSCO WC-0189n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-25
Filing Details
LAMIVUDINE USP
Lamivudine, SVL Process
Lamivudine EP
Issue/Submission Date
2004-10-08
2022-08-30
2022-06-08
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USDMF

Found USDMF

21474
Active
PIOGLITAZONE HYDROCHLORIDE USP
2008-03-22
CEP/COS

Found CEP/COS

R1-CEP 2012-315 - Rev 00
Valid
Pioglitazone hydrochloride
2018-09-27
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Pioglitazone Hydrochloride (Ph. Eur...
2022-06-22
Application Number
21474
Indian CDSCO WC-0117
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-28
Filing Details
PIOGLITAZONE HYDROCHLORIDE USP
Pioglitazone hydrochloride
Pioglitazone Hydrochloride (Ph. Eur...
Issue/Submission Date
2008-03-22
2018-09-27
2022-06-22
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USDMF

Found USDMF

17520
Active
RISPERIDONE USP
2004-07-13
CEP/COS

Found CEP/COS

R1-CEP 2006-060 - Rev 05
Valid
Risperidone
2019-05-02
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Risperidone (Ph. Eur.)
2022-06-22
Application Number
17520
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-28
Filing Details
RISPERIDONE USP
Risperidone
Risperidone (Ph. Eur.)
Issue/Submission Date
2004-07-13
2019-05-02
2022-06-22
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USDMF

Found USDMF

23766
Active
ROSUVASTATIN CALCIUM
2010-04-27
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

228MF10114
Rosuvastatin calcium at Plot No. 56...
2016-06-17
Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Rosuvastatin Calcium (1H)
2022-06-22
Application Number
23766
228MF10114
Indian CDSCO WC-0117
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-28
Filing Details
ROSUVASTATIN CALCIUM
Rosuvastatin calcium at Plot No. 56...
Rosuvastatin Calcium (1H)
Issue/Submission Date
2010-04-27
2016-06-17
2022-06-22
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USDMF

Found USDMF

20109
Active
TELMISARTAN USP
2007-01-03
CEP/COS

Found CEP/COS

CEP 2008-256 - Rev 02
Valid
Telmisartan
2023-10-04
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Telmisartan USP/EP
2022-06-22
Application Number
20109
Indian CDSCO WC-0117
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-28
Filing Details
TELMISARTAN USP
Telmisartan
Telmisartan USP/EP
Issue/Submission Date
2007-01-03
2023-10-04
2022-06-22
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USDMF

Found USDMF

32293
Active
VERAPAMIL HYDROCHLORIDE USP
2017-12-22
CEP/COS

Found CEP/COS

R0-CEP 2018-204 - Rev 00
Valid
Verapamil hydrochloride
2021-01-18
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Verapamil Hydrochloride EP
2022-06-22
Application Number
32293
Indian CDSCO WC-0117
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-28
Filing Details
VERAPAMIL HYDROCHLORIDE USP
Verapamil hydrochloride
Verapamil Hydrochloride EP
Issue/Submission Date
2017-12-22
2021-01-18
2022-06-22
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USDMF

Found USDMF

20639
Active
ZOLMITRIPTAN USP
2007-06-23
CEP/COS

Found CEP/COS

CEP 2020-422 - Rev 01
Valid
Zolmitriptan
2023-10-13
Japanese DMF

Close JDMF

Written Confirmation

Found WC

Indian CDSCO WC-0117
Valid
Zolmitriptan (IH)
2022-06-22
Application Number
20639
Indian CDSCO WC-0117
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-28
Filing Details
ZOLMITRIPTAN USP
Zolmitriptan
Zolmitriptan (IH)
Issue/Submission Date
2007-06-23
2023-10-13
2022-06-22
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USDMF

Found USDMF

18229
Active
ABACAVIR SULFATE USP
2005-03-30
CEP/COS

Found CEP/COS

R1-CEP 2013-141 - Rev 00
Valid
Abacavir sulfate
2019-05-31
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0015
Expired
Abacavir Sulfate USP/EP
2019-06-03
Application Number
18229
Indian CDSCO WC-0015
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-02
Filing Details
ABACAVIR SULFATE USP
Abacavir sulfate
Abacavir Sulfate USP/EP
Issue/Submission Date
2005-03-30
2019-05-31
2019-06-03
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USDMF

Found USDMF

20419
Active
ATAZANAVIR SULFATE
2007-03-27
CEP/COS

Found CEP/COS

R0-CEP 2019-203 - Rev 02
Valid
Atazanavir sulfate
2022-10-17
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0015
Expired
Atazanavir Sulfate (IH)
2019-06-03
Application Number
20419
Indian CDSCO WC-0015
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-06-02
Filing Details
ATAZANAVIR SULFATE
Atazanavir sulfate
Atazanavir Sulfate (IH)
Issue/Submission Date
2007-03-27
2022-10-17
2019-06-03
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USDMF

Found USDMF

21477
Active
ATORVASTATIN CALCIUM USP
2008-03-25
CEP/COS

Found CEP/COS

R1-CEP 2011-184 - Rev 02
Valid
Atorvastatin calcium
2022-08-10
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0015
Expired
Atrovastatin Calcium Trihydrate (Ph...
2019-06-03
Application Number
21477
Indian CDSCO WC-0015
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-02
Filing Details
ATORVASTATIN CALCIUM USP
Atorvastatin calcium
Atrovastatin Calcium Trihydrate (Ph...
Issue/Submission Date
2008-03-25
2022-08-10
2019-06-03
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USDMF

Found USDMF

18220
Active
BACLOFEN USP
2005-03-30
CEP/COS

Found CEP/COS

R1-CEP 2006-229 - Rev 01
Valid
Baclofen
2014-10-02
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0015
Expired
Baclofen USP/Ph. Eur
2019-06-03
Application Number
18220
Indian CDSCO WC-0015
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-02
Filing Details
BACLOFEN USP
Baclofen
Baclofen USP/Ph. Eur
Issue/Submission Date
2005-03-30
2014-10-02
2019-06-03
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USDMF

Found USDMF

18499
Active
CARVEDILOL USP
2005-07-12
CEP/COS

Found CEP/COS

R1-CEP 2005-267 - Rev 06
Valid
Carvedilol
2019-02-25
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0359
Expired
Carvedilol USP
2019-05-21
Application Number
18499
Indian CDSCO WC-0359
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-05-20
Filing Details
CARVEDILOL USP
Carvedilol
Carvedilol USP
Issue/Submission Date
2005-07-12
2019-02-25
2019-05-21
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USDMF

Found USDMF

17697
Active
CELECOXIB USP
2004-09-22
CEP/COS

Found CEP/COS

R1-CEP 2012-183 - Rev 03
Valid
Celecoxib
2023-02-15
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0016
Expired
Celecoxib USP/EP
2019-06-26
Application Number
17697
Indian CDSCO WC-0016
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-25
Filing Details
CELECOXIB USP
Celecoxib
Celecoxib USP/EP
Issue/Submission Date
2004-09-22
2023-02-15
2019-06-26
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USDMF

Found USDMF

18213
Active
ESCITALOPRAM OXALATE USP
2005-03-30
CEP/COS

Found CEP/COS

R0-CEP 2019-130 - Rev 01
Valid
Escitalopram oxalate, Process II
2023-07-13
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0359A4
Expired
Escitalopram Oxalate EP
2020-01-29
Application Number
18213
Indian CDSCO WC-0359A4
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-05-21
Filing Details
ESCITALOPRAM OXALATE USP
Escitalopram oxalate, Process II
Escitalopram Oxalate EP
Issue/Submission Date
2005-03-30
2023-07-13
2020-01-29
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USDMF

Found USDMF

18225
Active
GABAPENTIN USP
2005-03-30
CEP/COS

Found CEP/COS

R1-CEP 2011-185 - Rev 01
Valid
Gabapentin
2017-10-20
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0015
Expired
Gabapentin (Ph. Eur)
2019-06-03
Application Number
18225
Indian CDSCO WC-0015
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-06-02
Filing Details
GABAPENTIN USP
Gabapentin
Gabapentin (Ph. Eur)
Issue/Submission Date
2005-03-30
2017-10-20
2019-06-03
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USDMF

Found USDMF

17740
Active
LAMOTRIGINE USP
2004-10-08
CEP/COS

Found CEP/COS

R1-CEP 2009-157 - Rev 01
Valid
Lamotrigine
2017-09-07
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0117A2
Expired
Lamotrigine EP/USP
2019-08-13
Application Number
17740
Indian CDSCO WC-0117A2
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-07-28
Filing Details
LAMOTRIGINE USP
Lamotrigine
Lamotrigine EP/USP
Issue/Submission Date
2004-10-08
2017-09-07
2019-08-13
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USDMF

Found USDMF

19369
Active
MIRTAZAPINE USP (ANHYDROUS)
2006-04-14
CEP/COS

Found CEP/COS

R1-CEP 2008-205 - Rev 05
Valid
Mirtazapine
2022-04-06
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0016A2
Expired
Mirtazapine EP
2020-03-20
Application Number
19369
Indian CDSCO WC-0016A2
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-06-26
Filing Details
MIRTAZAPINE USP (ANHYDROUS)
Mirtazapine
Mirtazapine EP
Issue/Submission Date
2006-04-14
2022-04-06
2020-03-20
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USDMF

Found USDMF

17915
Active
NEVIRAPINE USP (ANHYDROUS)
2004-12-16
CEP/COS

Found CEP/COS

CEP 2011-075 - Rev 04
Valid
Nevirapine
2023-12-19
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0118
Expired
Nevirapine Anhydrous (Ph. Eur.)
2019-08-05
Application Number
17915
Indian CDSCO WC-0118
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-04
Filing Details
NEVIRAPINE USP (ANHYDROUS)
Nevirapine
Nevirapine Anhydrous (Ph. Eur.)
Issue/Submission Date
2004-12-16
2023-12-19
2019-08-05
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USDMF

Found USDMF

18228
Active
PANTOPRAZOLE SODIUM USP (SESQUIHYDR...
2005-03-30
CEP/COS

Found CEP/COS

R1-CEP 2008-244 - Rev 05
Valid
Pantoprazole sodium sesquihydrate
2022-12-07
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0016
Expired
Pantoprazole Sodium Sesquihydrate
2019-06-26
Application Number
18228
Indian CDSCO WC-0016
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-06-25
Filing Details
PANTOPRAZOLE SODIUM USP (SESQUIHYDR...
Pantoprazole sodium sesquihydrate
Pantoprazole Sodium Sesquihydrate
Issue/Submission Date
2005-03-30
2022-12-07
2019-06-26
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USDMF

Found USDMF

18869
Active
QUETIAPINE FUMARATE USP
2005-10-14
CEP/COS

Found CEP/COS

R1-CEP 2014-224 - Rev 02
Valid
Quetiapine Fumarate
2022-12-02
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0118
Expired
Quetiapine Fumarate (Ph. Eur./IH)
2019-08-05
Application Number
18869
Indian CDSCO WC-0118
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-08-04
Filing Details
QUETIAPINE FUMARATE USP
Quetiapine Fumarate
Quetiapine Fumarate (Ph. Eur./IH)
Issue/Submission Date
2005-10-14
2022-12-02
2019-08-05
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USDMF

Found USDMF

20398
Active
RISEDRONATE SODIUM USP (HEMI-PENTAH...
2007-04-02
CEP/COS

Found CEP/COS

R1-CEP 2013-009 - Rev 00
Valid
Risedronate sodium 2.5-hydrate
2018-10-18
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0015
Expired
Risedronate Sodium (Ph. Eur) II
2019-06-03
Application Number
20398
Indian CDSCO WC-0015
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-06-02
Filing Details
RISEDRONATE SODIUM USP (HEMI-PENTAH...
Risedronate sodium 2.5-hydrate
Risedronate Sodium (Ph. Eur) II
Issue/Submission Date
2007-04-02
2018-10-18
2019-06-03
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USDMF

Found USDMF

19800
Active
RITONAVIR USP (FORM-II)
2006-09-26
CEP/COS

Found CEP/COS

R1-CEP 2011-221 - Rev 01
Valid
Ritonavir, Form-II
2021-09-06
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0015
Expired
Ritonavir USP
2019-06-03
Application Number
19800
Indian CDSCO WC-0015
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-02
Filing Details
RITONAVIR USP (FORM-II)
Ritonavir, Form-II
Ritonavir USP
Issue/Submission Date
2006-09-26
2021-09-06
2019-06-03
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USDMF

Found USDMF

17751
Active
ZIDOVUDINE USP (PROCESS-I)
2004-10-08
CEP/COS

Found CEP/COS

R1-CEP 2007-318 - Rev 05
Valid
Zidovudine
2023-05-03
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0118
Expired
Zidovudine (Ph. Eur.)
2019-08-05
Application Number
17751
Indian CDSCO WC-0118
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-08-04
Filing Details
ZIDOVUDINE USP (PROCESS-I)
Zidovudine
Zidovudine (Ph. Eur.)
Issue/Submission Date
2004-10-08
2023-05-03
2019-08-05
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