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    List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by SMS Pharmaceuticals to the U.S. FDA. Original Data : FDA Website

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    Regd.off : Plot No:19-III, Road No:71, Jubilee Hills,Opp.Bharatiya Vidya Bhavan Public School, Hyderabad - 500034, Andhra Pradesh, India.
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    91 - 40 - 6628 8888
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    ALMOTRIPTAN MALATE

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    SMS PHARMACEUTICALS L...
    Active
    18962
    Complete
    2013-01-31
    2013-01-08
    2005-11-18
    II
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    APIXABAN

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    SMS PHARMACEUTICALS L...
    Active
    33520
    N/A
    2019-01-31
    II
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    ARIPIPRAZOLE

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    SMS PHARMACEUTICALS L...
    Inactive
    22339
    N/A
    2008-12-23
    II
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    ARIPIPRAZOLE USP

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    SMS PHARMACEUTICALS L...
    Active
    29991
    Complete
    2021-02-18
    2021-02-08
    2015-11-04
    II
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    EFAVIRENZ USP

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    SMS PHARMACEUTICALS L...
    Active
    34356
    N/A
    2021-03-17
    II
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    ELETRIPTAN HYDROBROMIDE MONOHYDRATE

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    SMS PHARMACEUTICALS L...
    Active
    24905
    Complete
    2014-03-04
    2013-09-25
    2011-05-02
    II
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    FAMOTIDINE USP

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    SMS PHARMACEUTICALS L...
    Active
    21442
    Complete
    2014-01-14
    2013-08-30
    2008-03-20
    II
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    HYDROXYCHLOROQUINE SULFATE USP

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    SMS PHARMACEUTICALS L...
    Active
    37131
    Complete
    2022-06-28
    2022-06-13
    2022-05-19
    II
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    IBUPROFEN USP

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    SMS PHARMACEUTICALS L...
    Active
    35215
    Complete
    2020-11-12
    2020-09-22
    2020-09-30
    II
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    IMIDAPRIL HYDROCHLORIDE

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    SMS PHARMACEUTICALS L...
    Active
    22705
    N/A
    2009-04-07
    II
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    ITRACONAZOLE USP

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    SMS PHARMACEUTICALS L...
    Active
    25514
    Complete
    2014-04-08
    2013-08-13
    2011-11-22
    II
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    LAMIVUDINE USP

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    SMS PHARMACEUTICALS L...
    Active
    34310
    N/A
    2019-11-26
    II
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    LAMOTRIGINE USP

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    SMS PHARMACEUTICALS L...
    Active
    34290
    Complete
    2023-10-24
    2023-09-26
    2019-11-20
    II
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    LANSOPRAZOLE USP

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    SMS PHARMACEUTICALS L...
    Inactive
    21552
    N/A
    2008-04-21
    II
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    LEVETIRACETAM USP

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    SMS PHARMACEUTICALS L...
    Active
    28431
    Complete
    2015-12-16
    2015-09-23
    2014-06-30
    II
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    MOLNUPIRAVIR

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    SMS PHARMACEUTICALS L...
    Active
    36770
    N/A
    2022-07-15
    II
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    NICOTINE POLACRILEX USP

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    SMS PHARMACEUTICALS L...
    Inactive
    21978
    N/A
    2008-09-16
    II
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    ONDANSETRON HYDROCHLORIDE USP

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    SMS PHARMACEUTICALS L...
    Active
    22340
    Complete
    2013-08-28
    2013-08-19
    2008-12-23
    II
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    PANTOPRAZOLE SODIUM SESQUIHYDRATE

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    SMS PHARMACEUTICALS L...
    Inactive
    22161
    N/A
    2008-11-10
    II
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    PANTOPRAZOLE SODIUM USP

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    SMS PHARMACEUTICALS L...
    Active
    29129
    Complete
    2016-04-21
    2015-09-09
    2015-03-04
    II
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    PENCICLOVIR

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    SMS PHARMACEUTICALS L...
    Active
    29724
    N/A
    2015-09-02
    II
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    PIRFENIDONE

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    SMS PHARMACEUTICALS L...
    Active
    37925
    N/A
    2022-12-31
    II
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    RAMIPRIL

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    SMS PHARMACEUTICALS L...
    Inactive
    17401
    N/A
    2004-05-20
    II
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    RANITIDINE HYDROCHLORIDE

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    SMS PHARMACEUTICALS L...
    Inactive
    17542
    N/A
    2004-07-13
    II
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    RANITIDINE HYDROCHLORIDE USP

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    SMS PHARMACEUTICALS L...
    Inactive
    18129
    N/A
    2005-03-03
    II
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    RANITIDINE HYDROCHLORIDE USP (PROCE...

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    SMS PHARMACEUTICALS L...
    Active
    31575
    Complete
    2017-07-11
    2017-05-31
    2017-03-16
    II
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    RANITIDINE HYDROCHLORIDE USP (UNIT-...

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    SMS PHARMACEUTICALS L...
    Inactive
    25608
    N/A
    2011-12-22
    II
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    RIVAROXABAN

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    SMS PHARMACEUTICALS L...
    Active
    34212
    N/A
    2020-06-27
    II
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    RIZATRIPTAN BENZOATE

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    SMS PHARMACEUTICALS L...
    Active
    23066
    Complete
    2013-10-18
    2013-05-24
    2009-08-26
    II
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    ROSIGLITAZONE MALEATE

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    SMS PHARMACEUTICALS L...
    Inactive
    22404
    N/A
    2009-01-16
    II
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    ROSIGLITAZONE MALEATE USP

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    SMS PHARMACEUTICALS L...
    Active
    29386
    Complete
    2015-12-15
    2015-09-04
    2015-05-14
    II
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    Sildenafil Citrate

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    SMS PHARMACEUTICALS L...
    Inactive
    21250
    N/A
    2008-01-22
    II
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    SILDENAFIL CITRATE (UNIT-II)

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    SMS PHARMACEUTICALS L...
    Active
    25358
    Complete
    2014-01-16
    2013-11-29
    2011-08-18
    II
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    SOLIFENACIN SUCCINATE

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    SMS PHARMACEUTICALS L...
    Active
    36133
    N/A
    2022-07-15
    II
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    SUMATRIPTAN SUCCINATE

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    SMS PHARMACEUTICALS L...
    Inactive
    16279
    N/A
    2002-12-02
    II
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    SUMATRIPTAN SUCCINATE (ALTERNATIVE ...

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    SMS PHARMACEUTICALS L...
    Active
    20746
    Complete
    2013-07-02
    2013-06-21
    2007-08-03
    II
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    SUMATRIPTAN USP

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    SMS PHARMACEUTICALS L...
    Inactive
    18287
    N/A
    2005-04-19
    II
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    SUMATRIPTAN USP (ALTERNATIVE SYNTHE...

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    SMS PHARMACEUTICALS L...
    Active
    20906
    Complete
    2013-08-13
    2013-08-02
    2007-10-03
    II
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    TADALAFIL

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    SMS PHARMACEUTICALS L...
    Active
    24206
    Complete
    2015-12-04
    2014-11-13
    2010-09-28
    II
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    VARDENAFIL HYDROCHLORIDE TRIHYDRATE...

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    SMS PHARMACEUTICALS L...
    Active
    32908
    N/A
    2018-09-20
    II
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    ZOLMITRIPTAN

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    SMS PHARMACEUTICALS L...
    Active
    20110
    Complete
    2015-05-04
    2015-04-21
    2007-01-04
    II
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