Athena Athena

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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by GlaxoSmithKline

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GSK
unitedkingdom_new Flag
Country
Country
United Kingdom
Address
Address
980 Great West Road, Brentford, Middlesex TW8 9GS England
Telephone
Telephone
+44 (0)20 8047 5000
Linkedin
Linkedin
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Twitter

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USDMF

Found USDMF

24411
Active
CEFUROXIME SODIUM
2011-03-01
CEP/COS

Found CEP/COS

R1-CEP 2005-208 - Rev 00
Valid
Cefuroxime sodium, Sterile
2013-07-02
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
24411
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
CEFUROXIME SODIUM
Cefuroxime sodium, Sterile
Issue/Submission Date
2011-03-01
2013-07-02
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USDMF

Found USDMF

31534
Active
FLUTICASONE PROPIONATE
2017-04-11
CEP/COS

Found CEP/COS

R0-CEP 2018-229 - Rev 01
Valid
Fluticasone propionate, Micronised
2020-12-07
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
31534
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
FLUTICASONE PROPIONATE
Fluticasone propionate, Micronised
Issue/Submission Date
2017-04-11
2020-12-07
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USDMF

Caution USDMF

13201
Inactive
AMOXICILLIN TRIHYDRATE
1998-04-30
CEP/COS

Found CEP/COS

R1-CEP 2015-064 - Rev 00
Valid
Amoxicillin trihydrate, Enzymatic p...
2021-03-03
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13201
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
AMOXICILLIN TRIHYDRATE
Amoxicillin trihydrate, Enzymatic p...
Issue/Submission Date
1998-04-30
2021-03-03
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USDMF

Caution USDMF

13207
Inactive
AMOXICILLIN TRIHYDRATE
1998-04-30
CEP/COS

Found CEP/COS

R1-CEP 2000-010 - Rev 04
Valid
Amoxicillin trihydrate
2018-06-04
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
13207
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
AMOXICILLIN TRIHYDRATE
Amoxicillin trihydrate
Issue/Submission Date
1998-04-30
2018-06-04
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USDMF

Caution USDMF

4578
Inactive
BETAMETHASONE VALERATE
1982-06-09
CEP/COS

Found CEP/COS

R1-CEP 2002-219 - Rev 08
Valid
Betamethasone valerate, Micronised
2023-07-10
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
4578
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
BETAMETHASONE VALERATE
Betamethasone valerate, Micronised
Issue/Submission Date
1982-06-09
2023-07-10
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USDMF

Caution USDMF

13650
Inactive
CEFTAZIDIME PENTAHYDRATE BULK DRUG ...
2000-08-10
CEP/COS

Found CEP/COS

R1-CEP 2004-306 - Rev 01
Valid
Ceftazidime Pentahydrate
2013-07-02
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13650
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
CEFTAZIDIME PENTAHYDRATE BULK DRUG ...
Ceftazidime Pentahydrate
Issue/Submission Date
2000-08-10
2013-07-02
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USDMF

Caution USDMF

4349
Inactive
CLAVULANATE POTASSIUM, BULK FORMS
1981-12-02
CEP/COS

Found CEP/COS

R1-CEP 1999-113 - Rev 04
Valid
Potassium clavulanate, Sterile
2014-02-26
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
4349
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
CLAVULANATE POTASSIUM, BULK FORMS
Potassium clavulanate, Sterile
Issue/Submission Date
1981-12-02
2014-02-26
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USDMF

Caution USDMF

5701
Inactive
PROCESSING OF STERILE BULK CLAVULAN...
1985-02-13
CEP/COS

Found CEP/COS

R1-CEP 1999-111 - Rev 03
Valid
Potassium clavulanate
2018-08-03
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
5701
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
PROCESSING OF STERILE BULK CLAVULAN...
Potassium clavulanate
Issue/Submission Date
1985-02-13
2018-08-03
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USDMF

Caution USDMF

7048
Inactive
CLAVULANATE POTASSIUM
1987-07-09
CEP/COS

Found CEP/COS

R1-CEP 2005-244 - Rev 01
Valid
Potassium clavulanate, diluted, Mic...
2017-12-01
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
7048
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
CLAVULANATE POTASSIUM
Potassium clavulanate, diluted, Mic...
Issue/Submission Date
1987-07-09
2017-12-01
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USDMF

Caution USDMF

25444
Inactive
CLOBETASOL PROPIONATE
2012-12-20
CEP/COS

Found CEP/COS

R1-CEP 2011-034 - Rev 03
Valid
Clobetasol propionate, Montrose sit...
2022-10-28
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25444
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
CLOBETASOL PROPIONATE
Clobetasol propionate, Montrose sit...
Issue/Submission Date
2012-12-20
2022-10-28
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 1997-015 - Rev 02
Valid
Beclometasone dipropionate
2007-10-05
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Beclometasone dipropionate
Issue/Submission Date
2007-10-05
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USDMF

Found USDMF

24339
Active
CEFTAZIDIME
2011-03-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
24339
Status
Active
Fees Paid
N/A
 
Filing Details
CEFTAZIDIME
Issue/Submission Date
2011-03-01
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USDMF

Caution USDMF

14992
Inactive
CEFUROXIME AXETIL BULK DRUG SUBSTAN...
2000-08-10
CEP/COS

Caution CEP/COS

R1-CEP 2002-050 - Rev 02
Withdrawn by Holder
Cefuroxime axetil
2013-07-02
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
14992
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
CEFUROXIME AXETIL BULK DRUG SUBSTAN...
Cefuroxime axetil
Issue/Submission Date
2000-08-10
2013-07-02
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USDMF

Caution USDMF

16005
Inactive
CLAVULANATE POTASSIUM STERILE BULK
2002-06-13
CEP/COS

Caution CEP/COS

R0-CEP 2006-068 - Rev 01
Withdrawn by Holder
Potassium clavulanate, diluted, sil...
2010-02-02
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
16005
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
CLAVULANATE POTASSIUM STERILE BULK
Potassium clavulanate, diluted, sil...
Issue/Submission Date
2002-06-13
2010-02-02
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2002-248 - Rev 05
Valid
Clobetasone butyrate, Micronised
2015-04-13
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Clobetasone butyrate, Micronised
Issue/Submission Date
2015-04-13
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USDMF

Found USDMF

31938
Active
FLUTICASONE FUROATE
2017-09-08
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
31938
Status
Active
Fees Paid
N/A
 
Filing Details
FLUTICASONE FUROATE
Issue/Submission Date
2017-09-08
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USDMF

Found USDMF

32952
Active
FLUTICASONE PROPIONATE
2018-08-22
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
32952
Status
Active
Fees Paid
N/A
 
Filing Details
FLUTICASONE PROPIONATE
Issue/Submission Date
2018-08-22
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USDMF

Caution USDMF

13338
Inactive
GRISEOFULVIN
1998-09-01
CEP/COS

Caution CEP/COS

R0-CEP 2000-374 - Rev 01
Withdrawn by Holder
Griseofulvin
2001-11-21
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13338
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
GRISEOFULVIN
Griseofulvin
Issue/Submission Date
1998-09-01
2001-11-21
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USDMF

Caution USDMF

5715
Inactive
LABETALOL HYDROCHLORIDE
1985-02-11
CEP/COS

Caution CEP/COS

R1-CEP 1998-119 - Rev 01
Withdrawn by Holder
Labetalol Hydrochloride
2008-07-16
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
5715
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
LABETALOL HYDROCHLORIDE
Labetalol Hydrochloride
Issue/Submission Date
1985-02-11
2008-07-16
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2010-146 - Rev 01
Valid
Mupirocin
2017-10-02
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Mupirocin
Issue/Submission Date
2017-10-02
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USDMF

Caution USDMF

13961
Inactive
MUPIROCIN FREE ACID AND MUPIROCIN C...
1999-01-29
CEP/COS

Caution CEP/COS

R1-CEP 2011-048 - Rev 00
Withdrawn by Holder
Mupirocin calcium
2017-06-02
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13961
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
MUPIROCIN FREE ACID AND MUPIROCIN C...
Mupirocin calcium
Issue/Submission Date
1999-01-29
2017-06-02
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USDMF

Found USDMF

15039
Active
PAROXETINE HYDROCHLORIDE HEMIHYDRAT...
2000-09-15
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

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Application Number
15039
Status
Active
Fees Paid
N/A
 
Filing Details
PAROXETINE HYDROCHLORIDE HEMIHYDRAT...
Issue/Submission Date
2000-09-15
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USDMF

Found USDMF

25189
Active
ALBUTEROL
2011-12-21
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

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Application Number
25189
Status
Active
Fees Paid
N/A
 
Filing Details
ALBUTEROL
Issue/Submission Date
2011-12-21
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USDMF

Found USDMF

24582
Active
SALMETEROL XINAFOATE
2011-03-23
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

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Application Number
24582
Status
Active
Fees Paid
N/A
 
Filing Details
SALMETEROL XINAFOATE
Issue/Submission Date
2011-03-23
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USDMF

Found USDMF

26339
Active
UMECLIDINIUM BROMIDE
2012-11-29
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
26339
Status
Active
Fees Paid
N/A
 
Filing Details
UMECLIDINIUM BROMIDE
Issue/Submission Date
2012-11-29
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USDMF

Found USDMF

25906
Active
VILANTEROL TRIFENATATE (GW642444)
2012-06-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25906
Status
Active
Fees Paid
N/A
 
Filing Details
VILANTEROL TRIFENATATE (GW642444)
Issue/Submission Date
2012-06-19
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USDMF

Caution USDMF

12933
Inactive
6-AMINOPENICILLANIC ACID [6-APA]
1998-03-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
12933
Status
Inactive
Fees Paid
N/A
 
Filing Details
6-AMINOPENICILLANIC ACID [6-APA]
Issue/Submission Date
1998-03-31
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USDMF

Caution USDMF

13481
Inactive
AMOXICILLIN TRIHYDRATE
1998-09-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13481
Status
Inactive
Fees Paid
N/A
 
Filing Details
AMOXICILLIN TRIHYDRATE
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

13297
Inactive
AMPICILLIN
1998-09-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13297
Status
Inactive
Fees Paid
N/A
 
Filing Details
AMPICILLIN
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

13480
Inactive
AMPICILLIN SODIUM
1998-09-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13480
Status
Inactive
Fees Paid
N/A
 
Filing Details
AMPICILLIN SODIUM
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

13299
Inactive
AMPICILLIN TRIHYDRATE
1998-09-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13299
Status
Inactive
Fees Paid
N/A
 
Filing Details
AMPICILLIN TRIHYDRATE
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

13479
Inactive
AMPICILLIN TRIHYDRATE
1998-09-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13479
Status
Inactive
Fees Paid
N/A
 
Filing Details
AMPICILLIN TRIHYDRATE
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

10179
Inactive
PENICILLIN G INTERMEDIATES
1989-06-08
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10179
Status
Inactive
Fees Paid
N/A
 
Filing Details
PENICILLIN G INTERMEDIATES
Issue/Submission Date
1989-06-08
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USDMF

Caution USDMF

13447
Inactive
CARBENICILLIN INDANYL SODIUM
1998-09-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13447
Status
Inactive
Fees Paid
N/A
 
Filing Details
CARBENICILLIN INDANYL SODIUM
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

11805
Inactive
CIMETIDINE
1996-01-11
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
11805
Status
Inactive
Fees Paid
N/A
 
Filing Details
CIMETIDINE
Issue/Submission Date
1996-01-11
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USDMF

Caution USDMF

13476
Inactive
CLOXACILLIN BENZATHINE
1998-09-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13476
Status
Inactive
Fees Paid
N/A
 
Filing Details
CLOXACILLIN BENZATHINE
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

13474
Inactive
CLOXACILLIN SODIUM
1998-09-01
CEP/COS

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Japanese DMF

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Application Number
13474
Status
Inactive
Fees Paid
N/A
 
Filing Details
CLOXACILLIN SODIUM
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

13405
Inactive
METHICILLIN SODIUM
1998-09-01
CEP/COS

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Japanese DMF

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Application Number
13405
Status
Inactive
Fees Paid
N/A
 
Filing Details
METHICILLIN SODIUM
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

13470
Inactive
METHICILLIN SODIUM
1998-09-01
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
13470
Status
Inactive
Fees Paid
N/A
 
Filing Details
METHICILLIN SODIUM
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

13386
Inactive
OXACILLIN SODIUM MONOHYDRATE
1998-09-01
CEP/COS

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Application Number
13386
Status
Inactive
Fees Paid
N/A
 
Filing Details
OXACILLIN SODIUM MONOHYDRATE
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

11041
Inactive
PENICILLIN G POTASSIUM, NON-STERILE...
1994-06-24
CEP/COS

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Japanese DMF

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Application Number
11041
Status
Inactive
Fees Paid
N/A
 
Filing Details
PENICILLIN G POTASSIUM, NON-STERILE...
Issue/Submission Date
1994-06-24
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USDMF

Caution USDMF

13449
Inactive
PENICILLIN G POTASSIUM
1998-09-01
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
13449
Status
Inactive
Fees Paid
N/A
 
Filing Details
PENICILLIN G POTASSIUM
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

13475
Inactive
PENICILLIN G POTASSIUM
1998-09-01
CEP/COS

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Application Number
13475
Status
Inactive
Fees Paid
N/A
 
Filing Details
PENICILLIN G POTASSIUM
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

13401
Inactive
STREPTOMYCIN SULFATE
1998-09-01
CEP/COS

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Application Number
13401
Status
Inactive
Fees Paid
N/A
 
Filing Details
STREPTOMYCIN SULFATE
Issue/Submission Date
1998-09-01
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USDMF

Caution USDMF

13402
Inactive
DIHYDROSTREPTOMYCIN SULFATE
1998-09-01
CEP/COS

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Application Number
13402
Status
Inactive
Fees Paid
N/A
 
Filing Details
DIHYDROSTREPTOMYCIN SULFATE
Issue/Submission Date
1998-09-01
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MANUFACTURING PRODUCTION FACILITY IN TORONTO, CANADA

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USDMF

Caution USDMF

10055
Inactive
MANUFACTURING PRODUCTION FACILITY I...
1993-01-25
CEP/COS

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Japanese DMF

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Application Number
10055
Status
Inactive
Fees Paid
N/A
 
Filing Details
MANUFACTURING PRODUCTION FACILITY I...
Issue/Submission Date
1993-01-25
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BRL 47539 (2-ACETOXYMETHYL-4-IODOBUT-1-YL-ACETATE)

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USDMF

Caution USDMF

10266
Inactive
BRL 47539 (2-ACETOXYMETHYL-4-IODOBU...
1993-06-03
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
10266
Status
Inactive
Fees Paid
N/A
 
Filing Details
BRL 47539 (2-ACETOXYMETHYL-4-IODOBU...
Issue/Submission Date
1993-06-03
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BRL 47539 (2-ACETOXYMETHYL-4-IODOBUT-1-YL-ACETATE)

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USDMF

Caution USDMF

10267
Inactive
BRL 47539 (2-ACETOXYMETHYL-4-IODOBU...
1993-06-03
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
10267
Status
Inactive
Fees Paid
N/A
 
Filing Details
BRL 47539 (2-ACETOXYMETHYL-4-IODOBU...
Issue/Submission Date
1993-06-03
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MANUFACTURING FACILITY AT VERONA, ITALY.

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USDMF

Caution USDMF

10661
Inactive
MANUFACTURING FACILITY AT VERONA, I...
1994-01-05
CEP/COS

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Japanese DMF

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Application Number
10661
Status
Inactive
Fees Paid
N/A
 
Filing Details
MANUFACTURING FACILITY AT VERONA, I...
Issue/Submission Date
1994-01-05
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MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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USDMF

Caution USDMF

11400
Inactive
MANUFACTURING SITE, FACILITIES, PER...
1995-03-24
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
11400
Status
Inactive
Fees Paid
N/A
 
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1995-03-24
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