Athena Athena

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

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AstraZeneca
unitedkingdom_new Flag
Country
Country
United Kingdom
Address
Address
2 Kingdom Street, Paddington, London W2 6BD
Telephone
Telephone
+44 (0)20 7604 8000

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USDMF

Caution USDMF

4863
Inactive
OMEPRAZOLE CAPSULES
1983-03-31
CEP/COS

Found CEP/COS

R1-CEP 2000-125 - Rev 06
Valid
Omeprazole
2020-10-23
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
4863
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
OMEPRAZOLE CAPSULES
Omeprazole
Issue/Submission Date
1983-03-31
2020-10-23
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USDMF

Found USDMF

33171
Active
BUDESONIDE
2018-10-10
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
33171
Status
Active
Fees Paid
N/A
 
Filing Details
BUDESONIDE
Issue/Submission Date
2018-10-10
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USDMF

Found USDMF

31488
Active
GOSERELIN ACETATE
2017-04-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
31488
Status
Active
Fees Paid
N/A
 
Filing Details
GOSERELIN ACETATE
Issue/Submission Date
2017-04-21
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USDMF

Found USDMF

31489
Active
GOSERELIN ACETATE IMPLANT
2017-04-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
31489
Status
Active
Fees Paid
N/A
 
Filing Details
GOSERELIN ACETATE IMPLANT
Issue/Submission Date
2017-04-21
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

302MF40018
Medium / Medium Additives-Inebilizu...
2020-06-04
Written Confirmation

Close WC

Application Number
302MF40018
Status
 
Filing Details
Medium / Medium Additives-Inebilizu...
Issue/Submission Date
2020-06-04
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40003
Medium / Medium Additives-Inebilizu...
2021-01-26
Written Confirmation

Close WC

Application Number
303MF40003
Status
 
Filing Details
Medium / Medium Additives-Inebilizu...
Issue/Submission Date
2021-01-26
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40004
Medium / Medium Additives-Inebelizu...
2021-01-26
Written Confirmation

Close WC

Application Number
303MF40004
Status
 
Filing Details
Medium / Medium Additives-Inebelizu...
Issue/Submission Date
2021-01-26
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USDMF

Found USDMF

31140
Active
METOPROLOL SUCCINATE EXTENDED RELEA...
2016-12-05
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
31140
Status
Active
Fees Paid
N/A
 
Filing Details
METOPROLOL SUCCINATE EXTENDED RELEA...
Issue/Submission Date
2016-12-05
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USDMF

Found USDMF

12694
Active
PRILOSEC MUPS TABLETS (OMEPRAZOLE M...
1997-10-09
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
12694
Status
Active
Fees Paid
N/A
 
Filing Details
PRILOSEC MUPS TABLETS (OMEPRAZOLE M...
Issue/Submission Date
1997-10-09
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USDMF

Found USDMF

12726
Active
OMEPRAZOLE MAGNESIUM DRUG SUBSTANCE
1997-10-31
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
12726
Status
Active
Fees Paid
N/A
 
Filing Details
OMEPRAZOLE MAGNESIUM DRUG SUBSTANCE
Issue/Submission Date
1997-10-31
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USDMF

Found USDMF

31995
Active
ALBUTEROL SULFATE PRESSURISED INHAL...
2017-10-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
31995
Status
Active
Fees Paid
N/A
 
Filing Details
ALBUTEROL SULFATE PRESSURISED INHAL...
Issue/Submission Date
2017-10-06
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USDMF

Caution USDMF

7942
Inactive
TERBUTALINE SULPHATE
1989-03-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0129
Expired
Terbutaline Sulphate
2013-06-20
Application Number
7942
Indian CDSCO WC-0129
Status
Inactive
Fees Paid
N/A
 
Expired
2016-07-02
Filing Details
TERBUTALINE SULPHATE
Terbutaline Sulphate
Issue/Submission Date
1989-03-01
2013-06-20
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AZD2292

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USDMF

Found USDMF

37547
Active
AZD2292
2022-10-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
37547
Status
Active
Fees Paid
N/A
 
Filing Details
AZD2292
Issue/Submission Date
2022-10-21
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Medium/Medium additives/Nilsevimab (genetically recombi...

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

305MF40037
Medium/Medium additives/Nilsevimab ...
2023-11-15
Written Confirmation

Close WC

Application Number
305MF40037
Status
 
Filing Details
Medium/Medium additives/Nilsevimab ...
Issue/Submission Date
2023-11-15
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Medium/Medium additives/Nilsevimab (genetically recombi...

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

305MF40038
Medium/Medium additives/Nilsevimab ...
2023-11-15
Written Confirmation

Close WC

Application Number
305MF40038
Status
 
Filing Details
Medium/Medium additives/Nilsevimab ...
Issue/Submission Date
2023-11-15
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Medium/Medium additive/Nilsevimab (genetical recombinat...

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

305MF40039
Medium/Medium additive/Nilsevimab (...
2023-11-15
Written Confirmation

Close WC

Application Number
305MF40039
Status
 
Filing Details
Medium/Medium additive/Nilsevimab (...
Issue/Submission Date
2023-11-15
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Medium/Medium additive/Nilsevimab (genetically recombin...

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

305MF40040
Medium/Medium additive/Nilsevimab (...
2023-11-15
Written Confirmation

Close WC

Application Number
305MF40040
Status
 
Filing Details
Medium/Medium additive/Nilsevimab (...
Issue/Submission Date
2023-11-15
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Medium / Medium Additives Tralokinumab Inoculum Media

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40060
Medium / Medium Additives Tralokinu...
2021-09-02
Written Confirmation

Close WC

Application Number
303MF40060
Status
 
Filing Details
Medium / Medium Additives Tralokinu...
Issue/Submission Date
2021-09-02
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Medium / Medium Additives Tralokinumab Production Media

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40061
Medium / Medium Additives Tralokinu...
2021-09-02
Written Confirmation

Close WC

Application Number
303MF40061
Status
 
Filing Details
Medium / Medium Additives Tralokinu...
Issue/Submission Date
2021-09-02
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Medium / Medium Additives / Ineviliumab Production Medi...

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

303MF40041
Medium / Medium Additives / Inevili...
2021-07-06
Written Confirmation

Close WC

Application Number
303MF40041
Status
 
Filing Details
Medium / Medium Additives / Inevili...
Issue/Submission Date
2021-07-06
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Media/Media Additives Tralokinumab Production Media in ...

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF40032
Media/Media Additives Tralokinumab ...
2022-09-21
Written Confirmation

Close WC

Application Number
304MF40032
Status
 
Filing Details
Media/Media Additives Tralokinumab ...
Issue/Submission Date
2022-09-21
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Media/Media Additives Tralokinumab Production Media in ...

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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF40033
Media/Media Additives Tralokinumab ...
2022-09-21
Written Confirmation

Close WC

Application Number
304MF40033
Status
 
Filing Details
Media/Media Additives Tralokinumab ...
Issue/Submission Date
2022-09-21
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USDMF

Caution USDMF

15099
Inactive
ACYCLOVIR USP, BULK
2000-10-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
15099
Status
Inactive
Fees Paid
N/A
 
Filing Details
ACYCLOVIR USP, BULK
Issue/Submission Date
2000-10-18
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USDMF

Caution USDMF

6905
Inactive
ATENOLOL
1987-03-30
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
6905
Status
Inactive
Fees Paid
N/A
 
Filing Details
ATENOLOL
Issue/Submission Date
1987-03-30
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USDMF

Caution USDMF

7101
Inactive
ATENOLOL ACETATE
1987-08-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
7101
Status
Inactive
Fees Paid
N/A
 
Filing Details
ATENOLOL ACETATE
Issue/Submission Date
1987-08-06
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USDMF

Caution USDMF

12149
Inactive
ATENOLOL BULK DRUG
1996-10-07
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
12149
Status
Inactive
Fees Paid
N/A
 
Filing Details
ATENOLOL BULK DRUG
Issue/Submission Date
1996-10-07
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USDMF

Caution USDMF

11487
Inactive
TCV-116
1995-05-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
11487
Status
Inactive
Fees Paid
N/A
 
Filing Details
TCV-116
Issue/Submission Date
1995-05-01
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USDMF

Caution USDMF

3003
Inactive
CHLORHEXIDINE GLUCONATE 20% SOLUTIO...
1977-08-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
3003
Status
Inactive
Fees Paid
N/A
 
Filing Details
CHLORHEXIDINE GLUCONATE 20% SOLUTIO...
Issue/Submission Date
1977-08-12
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USDMF

Caution USDMF

13157
Inactive
EXENDIN-4 INJECTION DRUG PRODUCT
1998-08-27
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
13157
Status
Inactive
Fees Paid
N/A
 
Filing Details
EXENDIN-4 INJECTION DRUG PRODUCT
Issue/Submission Date
1998-08-27
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USDMF

Caution USDMF

6036
Inactive
FOSCARNET SODIUM INTRAVENOUS SOLUTI...
1985-10-02
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
6036
Status
Inactive
Fees Paid
N/A
 
Filing Details
FOSCARNET SODIUM INTRAVENOUS SOLUTI...
Issue/Submission Date
1985-10-02
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USDMF

Caution USDMF

10295
Inactive
HALOTHANE
1993-06-17
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10295
Status
Inactive
Fees Paid
N/A
 
Filing Details
HALOTHANE
Issue/Submission Date
1993-06-17
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USDMF

Caution USDMF

28206
Inactive
METOPROLOL SUCCINATE EXTENDED RELEA...
2014-05-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28206
Status
Inactive
Fees Paid
N/A
 
Filing Details
METOPROLOL SUCCINATE EXTENDED RELEA...
Issue/Submission Date
2014-05-21
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USDMF

Caution USDMF

6911
Inactive
ZESTRIL (LISINOPRIL) TABLETS
1987-04-08
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
6911
Status
Inactive
Fees Paid
N/A
 
Filing Details
ZESTRIL (LISINOPRIL) TABLETS
Issue/Submission Date
1987-04-08
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USDMF

Caution USDMF

7141
Inactive
LISINOPRIL DIHYDRATE
1987-09-14
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
7141
Status
Inactive
Fees Paid
N/A
 
Filing Details
LISINOPRIL DIHYDRATE
Issue/Submission Date
1987-09-14
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USDMF

Caution USDMF

10853
Inactive
LISINOPRIL BULK DRUG
1994-04-08
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10853
Status
Inactive
Fees Paid
N/A
 
Filing Details
LISINOPRIL BULK DRUG
Issue/Submission Date
1994-04-08
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USDMF

Caution USDMF

10066
Inactive
SDM-70 NITROGLYCERIN/POLYMER MIXTUR...
1993-02-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
10066
Status
Inactive
Fees Paid
N/A
 
Filing Details
SDM-70 NITROGLYCERIN/POLYMER MIXTUR...
Issue/Submission Date
1993-02-01
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USDMF

Caution USDMF

8915
Inactive
DIPRIVAN
1991-01-04
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
8915
Status
Inactive
Fees Paid
N/A
 
Filing Details
DIPRIVAN
Issue/Submission Date
1991-01-04
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USDMF

Caution USDMF

5629
Inactive
TOCAINIDE HCL. INJECTION
1984-12-14
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
5629
Status
Inactive
Fees Paid
N/A
 
Filing Details
TOCAINIDE HCL. INJECTION
Issue/Submission Date
1984-12-14
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FACILITIES AND CONTROLS AT THE WESTBORO, MASS LOCATION

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USDMF

Caution USDMF

3923
Inactive
FACILITIES AND CONTROLS AT THE WEST...
1980-08-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
3923
Status
Inactive
Fees Paid
N/A
 
Filing Details
FACILITIES AND CONTROLS AT THE WEST...
Issue/Submission Date
1980-08-18
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POLYOXYETHYLENE FAT. ACID ESTERS

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USDMF

Caution USDMF

4039
Inactive
POLYOXYETHYLENE FAT. ACID ESTERS
1980-04-22
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
4039
Status
Inactive
Fees Paid
N/A
 
Filing Details
POLYOXYETHYLENE FAT. ACID ESTERS
Issue/Submission Date
1980-04-22
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LEUKOTRIENES

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USDMF

Caution USDMF

4347
Inactive
LEUKOTRIENES
1981-12-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
4347
Status
Inactive
Fees Paid
N/A
 
Filing Details
LEUKOTRIENES
Issue/Submission Date
1981-12-03
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MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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USDMF

Caution USDMF

4945
Inactive
MANUFACTURING SITE, FACILITIES, PER...
1983-04-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
4945
Status
Inactive
Fees Paid
N/A
 
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1983-04-28
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MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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USDMF

Caution USDMF

4952
Inactive
MANUFACTURING SITE, FACILITIES, PER...
1983-04-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
4952
Status
Inactive
Fees Paid
N/A
 
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1983-04-28
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MANUFACTURING SITE, FACILITIES, PERSONNEL, AND GENERAL ...

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USDMF

Caution USDMF

5345
Inactive
MANUFACTURING SITE, FACILITIES, PER...
1984-05-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
5345
Status
Inactive
Fees Paid
N/A
 
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1984-05-03
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COSMOCIL CQ (POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE)

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USDMF

Caution USDMF

6659
Inactive
COSMOCIL CQ (POLYHEXAMETHYLENE BIGU...
1986-10-28
CEP/COS

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Japanese DMF

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Application Number
6659
Status
Inactive
Fees Paid
N/A
 
Filing Details
COSMOCIL CQ (POLYHEXAMETHYLENE BIGU...
Issue/Submission Date
1986-10-28
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SDM 70

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USDMF

Caution USDMF

8099
Inactive
SDM 70
1989-06-13
CEP/COS

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Japanese DMF

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Application Number
8099
Status
Inactive
Fees Paid
N/A
 
Filing Details
SDM 70
Issue/Submission Date
1989-06-13
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HUMANIZED MONOCLONAL ANTIBODY (HULM609) TO HUMAN VITRON...

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USDMF

Caution USDMF

18645
Inactive
HUMANIZED MONOCLONAL ANTIBODY (HULM...
1996-12-23
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
18645
Status
Inactive
Fees Paid
N/A
 
Filing Details
HUMANIZED MONOCLONAL ANTIBODY (HULM...
Issue/Submission Date
1996-12-23
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SIPLIZUMAB [HUMANIZED MONOCLONAL ANTIBODY (MEDI-507) (N...

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USDMF

Caution USDMF

18647
Inactive
SIPLIZUMAB [HUMANIZED MONOCLONAL AN...
1997-03-27
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
18647
Status
Inactive
Fees Paid
N/A
 
Filing Details
SIPLIZUMAB [HUMANIZED MONOCLONAL AN...
Issue/Submission Date
1997-03-27
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HUMANIZED MONOCLONAL ANTIBODY (MEDI-522) TO THE VITRONE...

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USDMF

Caution USDMF

18671
Inactive
HUMANIZED MONOCLONAL ANTIBODY (MEDI...
2001-03-13
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
18671
Status
Inactive
Fees Paid
N/A
 
Filing Details
HUMANIZED MONOCLONAL ANTIBODY (MEDI...
Issue/Submission Date
2001-03-13
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
Status
 
Filing Details
Issue/Submission Date
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