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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Roche Diagnostics GmbH

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Roche Diagnostics GmbH
Germany Flag
Country
Country
Germany
Address
Address
Sandhofer Strasse 116 P.O. Box 310120 Mannheim, 68305
Telephone
Telephone
+49 621 759 0
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Twitter

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USDMF

Caution USDMF

2277
Inactive
DIGOXIN PRODUCTS
1974-05-17
CEP/COS

Found CEP/COS

R1-CEP 1996-048 - Rev 02
Valid
Digoxin
2006-11-10
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
2277
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
DIGOXIN PRODUCTS
Digoxin
Issue/Submission Date
1974-05-17
2006-11-10
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USDMF

Caution USDMF

8650
Inactive
GALACTOSE, THERAPEUTIC GRADE
1990-07-03
CEP/COS

Caution CEP/COS

R1-CEP 1997-098 - Rev 02
Withdrawn by Holder
Galactose
2010-12-01
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
8650
Status
Inactive
Fees Unpaid
N/A
Withdrawn by Holder
 
Filing Details
GALACTOSE, THERAPEUTIC GRADE
Galactose
Issue/Submission Date
1990-07-03
2010-12-01
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 1999-094 - Rev 01
Valid
Doxepin hydrochloride
2008-07-21
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Doxepin hydrochloride
Issue/Submission Date
2008-07-21
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USDMF

Caution USDMF

9532
Inactive
GUAIACOL-O-ETHYLTOSYLATE
1992-02-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
9532
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
GUAIACOL-O-ETHYLTOSYLATE
Issue/Submission Date
1992-02-06
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USDMF

Caution USDMF

8225
Inactive
ADENOSINE DEAMINASE THERAPEUTIC GRA...
1989-09-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
8225
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
ADENOSINE DEAMINASE THERAPEUTIC GRA...
Issue/Submission Date
1989-09-21
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USDMF

Caution USDMF

3962
Inactive
AMINOPHYLLINE,ANHYDROUS(THEOPHYLLIN...
1980-09-25
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
3962
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
AMINOPHYLLINE,ANHYDROUS(THEOPHYLLIN...
Issue/Submission Date
1980-09-25
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USDMF

Caution USDMF

3966
Inactive
AMINOPHYLLINE, HYDROUS (THEOPHYLLIN...
1980-09-26
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
3966
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
AMINOPHYLLINE, HYDROUS (THEOPHYLLIN...
Issue/Submission Date
1980-09-26
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USDMF

Caution USDMF

17043
Inactive
GUAIACOL-O-ETHYLBENZYLAMINE HCL
2003-12-16
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
17043
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
GUAIACOL-O-ETHYLBENZYLAMINE HCL
Issue/Submission Date
2003-12-16
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USDMF

Caution USDMF

20587
Inactive
CARVEDILOL
2007-06-05
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
20587
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
CARVEDILOL
Issue/Submission Date
2007-06-05
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USDMF

Caution USDMF

8106
Inactive
CATALASE THERAPEUTIC GRADE
1989-06-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
8106
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
CATALASE THERAPEUTIC GRADE
Issue/Submission Date
1989-06-12
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USDMF

Caution USDMF

9468
Inactive
CYTOSINE - ARABINOFURANOSIDE
1991-12-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
9468
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
CYTOSINE - ARABINOFURANOSIDE
Issue/Submission Date
1991-12-18
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USDMF

Caution USDMF

4966
Inactive
D-PHENYLALANINE
1983-03-14
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
4966
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
D-PHENYLALANINE
Issue/Submission Date
1983-03-14
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USDMF

Caution USDMF

12277
Inactive
5-BROMO-2'-DEOXYURIDINE
1996-12-16
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
12277
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
5-BROMO-2'-DEOXYURIDINE
Issue/Submission Date
1996-12-16
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USDMF

Close USDMF

CEP/COS

Caution CEP/COS

R1-CEP 1997-085 - Rev 01
Withdrawn by Holder
Digitoxin
2005-06-23
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Withdrawn by Holder
 
Filing Details
Digitoxin
Issue/Submission Date
2005-06-23
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USDMF

Caution USDMF

2410
Inactive
DOXEPIN
1975-02-25
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
2410
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
DOXEPIN
Issue/Submission Date
1975-02-25
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USDMF

Caution USDMF

15429
Inactive
IBANDRONATE, EDITION I
2001-05-15
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
15429
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
IBANDRONATE, EDITION I
Issue/Submission Date
2001-05-15
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USDMF

Caution USDMF

3699
Inactive
5'-IODO-2'-DEOXYURIDINE (IDOXURIDIN...
1980-01-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
3699
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
5'-IODO-2'-DEOXYURIDINE (IDOXURIDIN...
Issue/Submission Date
1980-01-18
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USDMF

Caution USDMF

5435
Inactive
METAXALONE
1984-06-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
5435
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
METAXALONE
Issue/Submission Date
1984-06-28
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USDMF

Caution USDMF

3345
Inactive
ALPHA-METHYLDOPA, BULK FORM USP XIX
1978-10-11
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
3345
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
ALPHA-METHYLDOPA, BULK FORM USP XIX
Issue/Submission Date
1978-10-11
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USDMF

Caution USDMF

5316
Inactive
METHYLDOPATE HYDROCHLORIDE
1984-03-26
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
5316
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
METHYLDOPATE HYDROCHLORIDE
Issue/Submission Date
1984-03-26
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USDMF

Caution USDMF

11638
Inactive
D,L-METIPRANOLOL
1995-09-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
11638
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
D,L-METIPRANOLOL
Issue/Submission Date
1995-09-01
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USDMF

Caution USDMF

11918
Inactive
N-DECYLMETHYLSULFOXIDE
1996-04-09
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
11918
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
N-DECYLMETHYLSULFOXIDE
Issue/Submission Date
1996-04-09
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USDMF

Caution USDMF

7979
Inactive
NITROFURANTOIN MACROCRYSTALLINE
1989-03-17
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
7979
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
NITROFURANTOIN MACROCRYSTALLINE
Issue/Submission Date
1989-03-17
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USDMF

Caution USDMF

3972
Inactive
OXTRIPHYLLINE (CHOLINE THEOPHYLLINA...
1980-09-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
3972
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
OXTRIPHYLLINE (CHOLINE THEOPHYLLINA...
Issue/Submission Date
1980-09-12
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USDMF

Caution USDMF

8309
Inactive
PROPRANOLOL HYDROCHLORIDE
1989-11-10
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
8309
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
PROPRANOLOL HYDROCHLORIDE
Issue/Submission Date
1989-11-10
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USDMF

Caution USDMF

8377
Inactive
PROPYLTHIOURACIL
1990-01-15
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
8377
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
PROPYLTHIOURACIL
Issue/Submission Date
1990-01-15
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USDMF

Caution USDMF

11917
Inactive
4-EPITETRACYCLINE HYDROCHLORIDE
1996-04-09
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
11917
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
4-EPITETRACYCLINE HYDROCHLORIDE
Issue/Submission Date
1996-04-09
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USDMF

Caution USDMF

3355
Inactive
QUINIDINE GLUCONATE & SULFATE USP X...
1978-10-13
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
3355
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
QUINIDINE GLUCONATE & SULFATE USP X...
Issue/Submission Date
1978-10-13
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USDMF

Caution USDMF

9462
Inactive
QUININE SULFATE
1991-12-13
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
9462
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
QUININE SULFATE
Issue/Submission Date
1991-12-13
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USDMF

Caution USDMF

3350
Inactive
SPIRONOLACTONE (BULK FORM) USP XIX,...
1978-10-11
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
3350
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
SPIRONOLACTONE (BULK FORM) USP XIX,...
Issue/Submission Date
1978-10-11
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USDMF

Caution USDMF

16512
Inactive
SULFADOXINE
2003-03-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
16512
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
SULFADOXINE
Issue/Submission Date
2003-03-21
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USDMF

Caution USDMF

11919
Inactive
TOPICYCLINE
1996-04-09
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
11919
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
TOPICYCLINE
Issue/Submission Date
1996-04-09
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USDMF

Caution USDMF

2864
Inactive
DIHYDROXYPROPYLTHEOPHYLLINE (DYPHYL...
1977-02-24
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
2864
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
DIHYDROXYPROPYLTHEOPHYLLINE (DYPHYL...
Issue/Submission Date
1977-02-24
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USDMF

Caution USDMF

16851
Inactive
TORASEMIDE
2003-09-17
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
16851
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
TORASEMIDE
Issue/Submission Date
2003-09-17
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MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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USDMF

Caution USDMF

928
Inactive
MANUFACTURING SITE, FACILITIES, PER...
1965-12-09
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
928
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1965-12-09
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TABLETTING AND ENCAPSULATING FACILITIES

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USDMF

Caution USDMF

3141
Inactive
TABLETTING AND ENCAPSULATING FACILI...
1978-01-04
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
3141
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
TABLETTING AND ENCAPSULATING FACILI...
Issue/Submission Date
1978-01-04
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FACILITIES AND OPERATING PROCEDURES IN MANNHEIM, GERMAN...

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USDMF

Caution USDMF

8921
Inactive
FACILITIES AND OPERATING PROCEDURES...
1991-01-24
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
8921
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
FACILITIES AND OPERATING PROCEDURES...
Issue/Submission Date
1991-01-24
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PRODUCTION PLANT HC-B 4 AND EXTRACTION PLANT HC-B 10 IN...

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USDMF

Caution USDMF

9455
Inactive
PRODUCTION PLANT HC-B 4 AND EXTRACT...
1991-12-05
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
9455
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
PRODUCTION PLANT HC-B 4 AND EXTRACT...
Issue/Submission Date
1991-12-05
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CHEMICAL PLANT HC-B 21 LOCATED IN MANNHEIM, GERMANY

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USDMF

Caution USDMF

9502
Inactive
CHEMICAL PLANT HC-B 21 LOCATED IN M...
1992-01-13
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
9502
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
CHEMICAL PLANT HC-B 21 LOCATED IN M...
Issue/Submission Date
1992-01-13
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FRUCTOSE-1.6-BISPHOSPHATE

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USDMF

Caution USDMF

10478
Inactive
FRUCTOSE-1.6-BISPHOSPHATE
1993-09-17
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10478
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
FRUCTOSE-1.6-BISPHOSPHATE
Issue/Submission Date
1993-09-17
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MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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USDMF

Caution USDMF

11874
Inactive
MANUFACTURING SITE, FACILITIES, PER...
1996-02-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
11874
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1996-02-28
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BM 17.0744 NA (K-111)

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USDMF

Caution USDMF

16749
Inactive
BM 17.0744 NA (K-111)
2003-08-08
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
16749
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
BM 17.0744 NA (K-111)
Issue/Submission Date
2003-08-08
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