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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by F. Hoffmann-La Roche

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F. Hoffmann-La Roche
Switzerland Flag
Country
Country
Switzerland
Address
Address
Konzern-Hauptsitz Grenzacherstrasse 124 CH-4070 Basel
Telephone
Telephone
+41-61-688 1111
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Linkedin
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Twitter

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USDMF

Caution USDMF

13656
Inactive
CEFTRIAXONE SODIUM
1998-09-01
CEP/COS

Found CEP/COS

R1-CEP 2001-084 - Rev 01
Valid
Ceftriaxone sodium, Sterile
2008-05-06
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13656
Status
Inactive
Fees Unpaid
N/A
Valid
 
Filing Details
CEFTRIAXONE SODIUM
Ceftriaxone sodium, Sterile
Issue/Submission Date
1998-09-01
2008-05-06
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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

2373
Inactive
1a,25-DIHYDROXYCHOLECALCIFEROL (RO2...
1974-12-13
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

218MF10105
Cholecalciferol Cholecalciferol / V...
2006-01-30
Written Confirmation

Close WC

Application Number
2373
218MF10105
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
1a,25-DIHYDROXYCHOLECALCIFEROL (RO2...
Cholecalciferol Cholecalciferol / V...
Issue/Submission Date
1974-12-13
2006-01-30
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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Withdrawn by Holder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Withdrawn by Holder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 1998-124 - Rev 04
Valid
Bezafibrate
2010-11-26
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Bezafibrate
Issue/Submission Date
2010-11-26
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2002-001 - Rev 03
Valid
Carvedilol
2012-07-25
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Carvedilol
Issue/Submission Date
2012-07-25
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

218MF10104
Dextromethorphan hydrobromide Dextr...
2006-01-30
Written Confirmation

Close WC

Application Number
218MF10104
Status
 
Filing Details
Dextromethorphan hydrobromide Dextr...
Issue/Submission Date
2006-01-30
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

219MF10119
Japanese Pharmacopoeia dextromethor...
2007-03-23
Written Confirmation

Close WC

Application Number
219MF10119
Status
 
Filing Details
Japanese Pharmacopoeia dextromethor...
Issue/Submission Date
2007-03-23
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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

Found USDMF

3542
Active
SUCRALFATE
1979-06-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
3542
Status
Active
Fees Unpaid
N/A
 
Filing Details
SUCRALFATE
Issue/Submission Date
1979-06-12
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2000-066 - Rev 04
Valid
Sulfadoxine
2015-09-24
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Sulfadoxine
Issue/Submission Date
2015-09-24
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2005-210 - Rev 00
Valid
Torasemide
2011-09-30
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Torasemide
Issue/Submission Date
2011-09-30
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MSBA30K PEG REAGENT FOR MIRCERA (RO0503819)

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USDMF

Found USDMF

19630
Active
MSBA30K PEG REAGENT FOR MIRCERA (RO...
2006-06-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
19630
Status
Active
Fees Unpaid
N/A
 
Filing Details
MSBA30K PEG REAGENT FOR MIRCERA (RO...
Issue/Submission Date
2006-06-29
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Nemolizumab drug substance

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

302MF10069
Nemolizumab drug substance at 5-5-1...
2020-06-16
Written Confirmation

Close WC

Application Number
302MF10069
Status
 
Filing Details
Nemolizumab drug substance at 5-5-1...
Issue/Submission Date
2020-06-16
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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

2278
Inactive
CHLORPHENIRAMINE MALEATE 12 MG SRC
1974-05-23
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
2278
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
CHLORPHENIRAMINE MALEATE 12 MG SRC
Issue/Submission Date
1974-05-23
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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

Caution USDMF

2344
Inactive
LEVODOPA S.R.C. 300MG
1974-10-17
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
2344
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
LEVODOPA S.R.C. 300MG
Issue/Submission Date
1974-10-17
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USDMF

Caution USDMF

17321
Inactive
DESTAB(TM) FERROUS FUMARATE 90 S UL...
2004-04-16
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
17321
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
DESTAB(TM) FERROUS FUMARATE 90 S UL...
Issue/Submission Date
2004-04-16
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USDMF

Caution USDMF

1007
Inactive
COMPOSITION & GR OF INJECTABLE SOLU...
1966-11-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
1007
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
COMPOSITION & GR OF INJECTABLE SOLU...
Issue/Submission Date
1966-11-01
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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

12918
Inactive
OCT (MAXACALCITOL)
1998-03-26
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
12918
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
OCT (MAXACALCITOL)
Issue/Submission Date
1998-03-26
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USDMF

Caution USDMF

2310
Inactive
METHYLTESTOSTERONE
1974-07-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
2310
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
METHYLTESTOSTERONE
Issue/Submission Date
1974-07-30
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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

10579
Inactive
MICONAZOLE VAGINAL CREAM
1993-11-16
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10579
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
MICONAZOLE VAGINAL CREAM
Issue/Submission Date
1993-11-16
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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

2292
Inactive
PROCARBAZINE HYDROCHLORIDE PARENTER...
1974-06-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
2292
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
PROCARBAZINE HYDROCHLORIDE PARENTER...
Issue/Submission Date
1974-06-19
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USDMF

Caution USDMF

2154
Inactive
PSEUDOEPHEDRINE HCL 120MG S.R. CAPS...
1973-09-10
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
2154
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
PSEUDOEPHEDRINE HCL 120MG S.R. CAPS...
Issue/Submission Date
1973-09-10
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USDMF

Caution USDMF

11972
Inactive
PYRIDOSTIGMINE BROMIDE TABLETS USP ...
1996-05-10
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
11972
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
PYRIDOSTIGMINE BROMIDE TABLETS USP ...
Issue/Submission Date
1996-05-10
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USDMF

Caution USDMF

2162
Inactive
R03-0749/607 DISODIUM PYRIDOXAL PHO...
1973-10-04
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
2162
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
R03-0749/607 DISODIUM PYRIDOXAL PHO...
Issue/Submission Date
1973-10-04
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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

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

10496
Inactive
NITOMAN (TETRABENAZINE) TABLETS
1993-09-24
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10496
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
NITOMAN (TETRABENAZINE) TABLETS
Issue/Submission Date
1993-09-24
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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

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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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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PROTAMINE HCL, RO 6-1588/1

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USDMF

Caution USDMF

1037
Inactive
PROTAMINE HCL, RO 6-1588/1
1967-03-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
1037
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
PROTAMINE HCL, RO 6-1588/1
Issue/Submission Date
1967-03-01
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ORTHO-NOVUM 1/5OE21

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USDMF

Caution USDMF

1813
Inactive
ORTHO-NOVUM 1/5OE21
1971-10-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
1813
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
ORTHO-NOVUM 1/5OE21
Issue/Submission Date
1971-10-18
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B-AMINOPROPIONITRILE FUMARATE

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USDMF

Caution USDMF

2116
Inactive
B-AMINOPROPIONITRILE FUMARATE
1973-06-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
2116
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
B-AMINOPROPIONITRILE FUMARATE
Issue/Submission Date
1973-06-21
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MANUFACTURING FACILITIES AND CONTROLS

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USDMF

Caution USDMF

2189
Inactive
MANUFACTURING FACILITIES AND CONTRO...
1973-11-16
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
2189
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
MANUFACTURING FACILITIES AND CONTRO...
Issue/Submission Date
1973-11-16
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PSEUDOEPHEDRINE HCL & CHLORPHENIRAMINE MALEATE S.R.C.

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USDMF

Caution USDMF

2231
Inactive
PSEUDOEPHEDRINE HCL & CHLORPHENIRAM...
1973-08-17
CEP/COS

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Application Number
2231
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
PSEUDOEPHEDRINE HCL & CHLORPHENIRAM...
Issue/Submission Date
1973-08-17
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FACILITIES CONTROL PERSONNEL

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USDMF

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2236
Inactive
FACILITIES CONTROL PERSONNEL
1974-02-27
CEP/COS

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Application Number
2236
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
FACILITIES CONTROL PERSONNEL
Issue/Submission Date
1974-02-27
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ANTIPRESS TAB

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USDMF

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2409
Inactive
ANTIPRESS TAB
1975-01-21
CEP/COS

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Application Number
2409
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
ANTIPRESS TAB
Issue/Submission Date
1975-01-21
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INTERLEUKIN-2 (HUMAN, RECOMBINANT, E. COLI, HOFFMAN-LA ...

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USDMF

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19529
Inactive
INTERLEUKIN-2 (HUMAN, RECOMBINANT, ...
2006-06-19
CEP/COS

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Application Number
19529
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
INTERLEUKIN-2 (HUMAN, RECOMBINANT, ...
Issue/Submission Date
2006-06-19
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TUMOR NECROSIS FACTOR RECEPTOR IMMUNOGLOBULIN G

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USDMF

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18622
Inactive
TUMOR NECROSIS FACTOR RECEPTOR IMMU...
1993-11-11
CEP/COS

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Application Number
18622
Status
Inactive
Fees Paid
N/A
 
Filing Details
TUMOR NECROSIS FACTOR RECEPTOR IMMU...
Issue/Submission Date
1993-11-11
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THROMBOPOIETIN (HUMAN, RECOMBINANT, CHO CELLS, GENENTEC...

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USDMF

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18640
Inactive
THROMBOPOIETIN (HUMAN, RECOMBINANT,...
1995-08-21
CEP/COS

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Application Number
18640
Status
Inactive
Fees Paid
N/A
 
Filing Details
THROMBOPOIETIN (HUMAN, RECOMBINANT,...
Issue/Submission Date
1995-08-21
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DORNASE ALFA INHALATION SOLUTION (GENENTECH)

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USDMF

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18663
Inactive
DORNASE ALFA INHALATION SOLUTION (G...
1999-11-09
CEP/COS

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Application Number
18663
Status
Inactive
Fees Paid
N/A
 
Filing Details
DORNASE ALFA INHALATION SOLUTION (G...
Issue/Submission Date
1999-11-09
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