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

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01 ALPRAZOLAM (1)

02 AMITRIPTYLINE HYDROCHLORIDE (1)

03 CARBINOXAMINE MALEATE (1)

04 CHLORDIAZEPOXIDE (1)

05 CHLORPROMAZINE HYDROCHLORIDE (1)

06 CLOMIPRAMINE HYDROCHLORIDE (1)

07 CLONAZEPAM (1)

08 CLOZAPINE (1)

09 CYCLOBENZAPRINE HYDROCHLORIDE (1)

10 DIAZEPAM (1)

11 DOXEPIN HYDROCHLORIDE (1)

12 DOXYLAMINE SUCCINATE (1)

13 DULOXETINE HYDROCHLORIDE (1)

14 IMIPRAMINE PAMOATE (1)

15 IMIPRAMINE PAMOATE DRUG SUBSTANCE (1)

16 LORAZEPAM (1)

17 MECLIZINE HYDROCHLORIDE (2)

18 NORTRIPTYLINE HYDROCHLORIDE (1)

19 ORPHENADRINE CITRATE (2)

20 TEMAZEPAM (1)

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01 R L FINE CHEM (1)

02 R L FINE CHEM PVT LTD (10)

03 RL FINE CHEM PVT LTD (11)

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01 India (22)

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01 Active (21)

02 Inactive (1)

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01 Complete (11)

02 Blank (11)

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RL FINE CHEM PVT LTD
Active
33417
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2019-01-31
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RL FINE CHEM PVT LTD
Active
18111
Complete
2017-03-22
2016-09-26
2005-02-10
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R L FINE CHEM PVT LTD
Active
34110
Complete
2020-12-18
2020-11-12
2019-08-30
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R L FINE CHEM PVT LTD
Active
33972
N/A
2019-06-26
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RL FINE CHEM PVT LTD
Active
30731
Complete
2019-07-09
2018-11-15
2017-04-11
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RL FINE CHEM PVT LTD
Active
31942
Complete
2019-01-30
2018-09-28
2017-08-03
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R L FINE CHEM PVT LTD
Active
38070
Complete
2023-11-03
2023-09-22
2023-02-22
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R L FINE CHEM PVT LTD
Active
38071
N/A
2023-03-09
II
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RL FINE CHEM PVT LTD
Active
33147
Complete
2020-04-08
2020-03-04
2018-09-26
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R L FINE CHEM PVT LTD
Active
33858
Complete
2021-11-24
2021-09-20
2019-06-07
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