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

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    ROCHE DIAGNOSTICS GMBH

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    Roche Diagnostics GmbH
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    Sandhofer Strasse 116 P.O. Box 310120 Mannheim, 68305
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        5'-IODO-2'-DEOXYURIDINE (IDOXURIDIN...

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          5-BROMO-2'-DEOXYURIDINE

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            ADENOSINE DEAMINASE THERAPEUTIC GRA...

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              ALPHA-METHYLDOPA, BULK FORM USP XIX

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                AMINOPHYLLINE, HYDROUS (THEOPHYLLIN...

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                  AMINOPHYLLINE,ANHYDROUS(THEOPHYLLIN...

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                    CARVEDILOL

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                      CATALASE THERAPEUTIC GRADE

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                        CYTOSINE - ARABINOFURANOSIDE

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                        1991-12-18
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                          D,L-METIPRANOLOL

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                            D-PHENYLALANINE

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                            4966
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                            1983-03-14
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                              DIGOXIN PRODUCTS

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                              ROCHE DIAGNOSTICS GMB...
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                              2277
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                              1974-05-17
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                                DIHYDROXYPROPYLTHEOPHYLLINE (DYPHYL...

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                                  DOXEPIN

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                                    GALACTOSE, THERAPEUTIC GRADE

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                                    1990-07-03
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                                      GUAIACOL-O-ETHYLBENZYLAMINE HCL

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                                        GUAIACOL-O-ETHYLTOSYLATE

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                                        ROCHE DIAGNOSTICS GMB...
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                                        9532
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                                        1992-02-06
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                                          IBANDRONATE, EDITION I

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                                            METAXALONE

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                                            ROCHE DIAGNOSTICS GMB...
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                                            5435
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                                            1984-06-28
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                                              METHYLDOPATE HYDROCHLORIDE

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                                              1984-03-26
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                                                N-DECYLMETHYLSULFOXIDE

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                                                  NITROFURANTOIN MACROCRYSTALLINE

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                                                  7979
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                                                    OXTRIPHYLLINE (CHOLINE THEOPHYLLINA...

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                                                    3972
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                                                      PROPRANOLOL HYDROCHLORIDE

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                                                      BOEHRINGER KNOLL LTD
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                                                      8309
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                                                      1989-11-10
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                                                        PROPYLTHIOURACIL

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                                                        ROCHE DIAGNOSTICS GMB...
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                                                        8377
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                                                        1990-01-15
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                                                          QUINIDINE GLUCONATE & SULFATE USP X...

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                                                          ROCHE DIAGNOSTICS GMB...
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                                                          3355
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                                                          1978-10-13
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                                                            QUININE SULFATE

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                                                            1991-12-13
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                                                              SPIRONOLACTONE (BULK FORM) USP XIX,...

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                                                              3350
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                                                                SULFADOXINE

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                                                                2003-03-21
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                                                                  TOPICYCLINE

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                                                                    TORASEMIDE

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                                                                      BM 17.0744 NA (K-111)

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                                                                      16749
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                                                                      2003-08-08
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                                                                        CHEMICAL PLANT HC-B 21 LOCATED IN M...

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                                                                          FACILITIES AND OPERATING PROCEDURES...

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                                                                          8921
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                                                                          1991-01-24
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                                                                            FRUCTOSE-1.6-BISPHOSPHATE

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                                                                            ROCHE DIAGNOSTICS GMB...
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                                                                            10478
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                                                                            1993-09-17
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                                                                              MANUFACTURING SITE, FACILITIES, PER...

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                                                                              BOEHRINGER MANNHEIM S...
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                                                                                BOEHRINGER MANNHEIM G...
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                                                                                928
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                                                                                1965-12-09
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                                                                                  PRODUCTION PLANT HC-B 4 AND EXTRACT...

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                                                                                  9455
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                                                                                  1991-12-05
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                                                                                    TABLETTING AND ENCAPSULATING FACILI...

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                                                                                    3141
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                                                                                    1978-01-04
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