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

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01 ALPRAZOLAM DRUG SUBSTANCE (1)

02 ATORVASTATIN CALCIUM AMORPHOUS (NON-STERILE BULK DRUG SUBSTANCE) (1)

03 CLONAZEPAM (1)

04 COLCHICINE USP (1)

05 DARIFENACIN HYDROBROMIDE (NON STERILE BULK DRUG SUBSTANCE) (1)

06 FACILITIES AND CONTROLS (1)

07 LEVOFLOXACIN HEMIHYDRATE (NON-STERILE BULK DRUG SUBSTANCE) (1)

08 MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL OPERATING PROCEDURES IN SPRING VALLEY, NEW YORK. (1)

09 MIDODRINE HYDROCHLORIDE USP (1)

10 MOLINDONE HYDROCHLORIDE (1)

11 NISOLDIPINE NON STERILE BULK DRUG SUBSTANCE (1)

12 PALIPERIDONE (NON-STERILE BULK DRUG SUBSTANCE) (1)

13 PHENOXYBENZAMINE HYDROCHLORIDE USP (1)

14 PIMOZIDE USP (1)

15 PIOGLITAZONE HYDROCHLORIDE (NON-STERILE) DRUG SUBSTANCE (1)

16 PRAMIPEXOLE DIHYDROCHLORIDE USP (NON-STERILE BULK DRUG SUBSTANCE) (1)

17 QUETIAPINE HEMIFUMARATE (NON-STERILE BULK DRUG SUBSTANCE) (1)

18 RANOLAZINE (NON-STERILE BULK DRUG SUBSTANCE) (1)

19 RASAGILINE MESYLATE (NON STERILE BULK DRUG SUBSTANCE) (1)

20 ROSIGLITAZONE MALEATE (NON-STERILE BULK DRUG SUBSTANCE) (1)

21 SILDENAFIL CITRATE (NON-STERILE BULK DRUG SUBSTANCE) (1)

22 TIZANIDINE HYDROCHLORIDE, USP (1)

23 TOLCAPONE, USP (1)

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01 PAR ACTIVE TECHNOLOGIES PRIVATE LTD (15)

02 PAR PHARMACEUTICAL INC (8)

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01 India (13)

02 Israel (2)

03 U.S.A (8)

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01 Active (21)

02 Inactive (2)

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01 Complete (3)

02 Blank (20)

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PAR ACTIVE TECHNOLOGI...
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18075
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2005-02-06
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PAR ACTIVE TECHNOLOGI...
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24532
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2011-01-06
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PAR ACTIVE TECHNOLOGI...
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16245
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2002-11-15
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PAR PHARMACEUTICAL IN...
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27722
Complete
2014-05-05
2013-12-05
2013-12-06
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PAR ACTIVE TECHNOLOGI...
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23269
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2009-11-12
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PAR ACTIVE TECHNOLOGI...
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23382
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2009-12-17
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PAR PHARMACEUTICAL IN...
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28211
Complete
2014-07-01
2014-04-29
2014-04-30
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PAR ACTIVE TECHNOLOGI...
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19448
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2006-05-18
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PAR ACTIVE TECHNOLOGI...
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21106
N/A
2007-11-03
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PAR ACTIVE TECHNOLOGI...
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23830
N/A
2010-05-24
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