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

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PolyPeptide Group
Switzerland Flag
Country
Country
Switzerland
Address
Address
Dammstrasse 19 6300 Zug Switzerland
Telephone
Telephone
+41 (0) 41 723 20 40

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USDMF

Found USDMF

13150
Active
LEUPROLIDE
1998-08-21
CEP/COS

Found CEP/COS

R1-CEP 2003-045 - Rev 00
Valid
Leuprorelin
2009-02-13
Japanese DMF

Found JDMF

231MF10082
Leuprorelin Acetate at Ho(¨)geruds...
2019-04-03
Written Confirmation

Caution WC

Indian CDSCO WC-0047a3
Expired
Leuprolide Acetate USP/EP
2020-01-28
Application Number
13150
231MF10082
Indian CDSCO WC-0047a3
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-06-27
Filing Details
LEUPROLIDE
Leuprorelin
Leuprorelin Acetate at Ho(¨)geruds...
Leuprolide Acetate USP/EP
Issue/Submission Date
1998-08-21
2009-02-13
2019-04-03
2020-01-28
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USDMF

Found USDMF

8396
Active
DESMOPRESSIN
1990-01-26
CEP/COS

Found CEP/COS

R1-CEP 2006-266 - Rev 00
Valid
Desmopressin, 41006
2013-11-27
Japanese DMF

Found JDMF

224MF10122
Desmopressin at Ho(¨)gerudsgatan 2...
2012-07-09
Written Confirmation

Close WC

Application Number
8396
224MF10122
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
DESMOPRESSIN
Desmopressin, 41006
Desmopressin at Ho(¨)gerudsgatan 2...
Issue/Submission Date
1990-01-26
2013-11-27
2012-07-09
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USDMF

Found USDMF

19646
Active
EXENATIDE DRUG SUBSTANCE
2006-07-31
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

223MF10041
Eguzenataido at Chausse(')e de Tubi...
2011-03-10
Written Confirmation

Caution WC

Indian CDSCO WC-0047a3
Expired
EXENDIN-4 ACETATE IH/USP
2020-01-28
Application Number
19646
223MF10041
Indian CDSCO WC-0047a3
Status
Active
Fees Paid
N/A
 
Expired
2022-06-27
Filing Details
EXENATIDE DRUG SUBSTANCE
Eguzenataido at Chausse(')e de Tubi...
EXENDIN-4 ACETATE IH/USP
Issue/Submission Date
2006-07-31
2011-03-10
2020-01-28
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USDMF

Found USDMF

14994
Active
OCTREOTIDE ACETATE DRUG SUBSTANCE
2000-08-04
CEP/COS

Found CEP/COS

R0-CEP 2021-279 - Rev 00
Valid
Octreotide
2022-04-29
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0047
Expired
Octreotide Acetate IH/USP
2019-06-27
Application Number
14994
Indian CDSCO WC-0047
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-06-26
Filing Details
OCTREOTIDE ACETATE DRUG SUBSTANCE
Octreotide
Octreotide Acetate IH/USP
Issue/Submission Date
2000-08-04
2022-04-29
2019-06-27
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USDMF

Found USDMF

16813
Active
DESMOPRESSIN (ACETATE) (CODE SF278)
2003-09-03
CEP/COS

Found CEP/COS

R1-CEP 2000-142 - Rev 04
Valid
Desmopressin, 40001
2010-02-12
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
16813
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
DESMOPRESSIN (ACETATE) (CODE SF278)
Desmopressin, 40001
Issue/Submission Date
2003-09-03
2010-02-12
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2011-247 - Rev 01
Valid
Felypressin
2018-11-05
Japanese DMF

Found JDMF

220MF10039
Felypressin at Ho(¨)gerudsgatan 21...
2008-02-05
Written Confirmation

Close WC

Application Number
220MF10039
Status
Valid
 
Filing Details
Felypressin
Felypressin at Ho(¨)gerudsgatan 21...
Issue/Submission Date
2018-11-05
2008-02-05
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USDMF

Found USDMF

26832
Active
LEUPROLIDE ACETATE
2013-02-20
CEP/COS

Found CEP/COS

R1-CEP 2011-321 - Rev 02
Valid
Leuprorelin, Process F
2023-01-26
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
26832
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
LEUPROLIDE ACETATE
Leuprorelin, Process F
Issue/Submission Date
2013-02-20
2023-01-26
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USDMF

Found USDMF

22322
Active
PTH (1-34), HUMAN, ACETATE
2008-12-16
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

230MF10022
Teriparatide acetate at 365 Maple A...
2018-02-14
Written Confirmation

Close WC

Application Number
22322
230MF10022
Status
Active
Fees Paid
Reviewed
 
Filing Details
PTH (1-34), HUMAN, ACETATE
Teriparatide acetate at 365 Maple A...
Issue/Submission Date
2008-12-16
2018-02-14
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USDMF

Caution USDMF

12775
Inactive
CALCITONIN (SALMON), PH.EUR.
1997-12-02
CEP/COS

Found CEP/COS

R1-CEP 1997-091 - Rev 03
Valid
Calcitonin (salmon), Synthetic Orig...
2022-02-07
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
12775
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
CALCITONIN (SALMON), PH.EUR.
Calcitonin (salmon), Synthetic Orig...
Issue/Submission Date
1997-12-02
2022-02-07
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USDMF

Found USDMF

21473
Active
ALPHA-CORTICOTROPIN (1-24) ACETATE
2008-03-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0047a3
Expired
Corticotropin/ACTH IH
2020-01-28
Application Number
21473
Indian CDSCO WC-0047a3
Status
Active
Fees Paid
N/A
 
Expired
2022-06-27
Filing Details
ALPHA-CORTICOTROPIN (1-24) ACETATE
Corticotropin/ACTH IH
Issue/Submission Date
2008-03-28
2020-01-28
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USDMF

Found USDMF

23676
Active
DESMOPRESSIN ACETATE DRUG SUBSTANCE
2010-04-02
CEP/COS

Caution CEP/COS

R1-CEP 2012-037 - Rev 00
Withdrawn by Holder
Desmopressin, Liquid phase synthesi...
2017-07-12
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
23676
Status
Active
Fees Paid
Reviewed
Withdrawn by Holder
 
Filing Details
DESMOPRESSIN ACETATE DRUG SUBSTANCE
Desmopressin, Liquid phase synthesi...
Issue/Submission Date
2010-04-02
2017-07-12
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

R1-CEP 2010-169 - Rev 03
Valid
Somatostatin, F
2022-09-27
Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Indian CDSCO WC-0047a3
Expired
Somatostatin IH/EP
2020-01-28
Application Number
Indian CDSCO WC-0047a3
Status
Valid
 
Expired
2022-06-27
Filing Details
Somatostatin, F
Somatostatin IH/EP
Issue/Submission Date
2022-09-27
2020-01-28
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USDMF

Caution USDMF

25589
Inactive
TERLIPRESSIN ACETATE
2011-12-21
CEP/COS

Found CEP/COS

R0-CEP 2019-316 - Rev 00
Valid
Terlipressin
2021-05-21
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25589
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
TERLIPRESSIN ACETATE
Terlipressin
Issue/Submission Date
2011-12-21
2021-05-21
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USDMF

Found USDMF

12522
Active
ACYLINE
1997-05-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
12522
Status
Active
Fees Unpaid
N/A
 
Filing Details
ACYLINE
Issue/Submission Date
1997-05-12
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USDMF

Found USDMF

32116
Active
VASOPRESSIN
2017-10-03
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
32116
Status
Active
Fees Paid
Reviewed
 
Filing Details
VASOPRESSIN
Issue/Submission Date
2017-10-03
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USDMF

Found USDMF

12797
Active
HIRULOG (BIVALIRUDIN)- ACTIVE PHARM...
1997-12-22
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
12797
Status
Active
Fees Paid
N/A
 
Filing Details
HIRULOG (BIVALIRUDIN)- ACTIVE PHARM...
Issue/Submission Date
1997-12-22
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USDMF

Found USDMF

28912
Active
BIVALIRUDIN (TM-001-2G)
2014-12-05
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
28912
Status
Active
Fees Paid
N/A
 
Filing Details
BIVALIRUDIN (TM-001-2G)
Issue/Submission Date
2014-12-05
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USDMF

Found USDMF

15684
Active
CALCITONIN (SALMON)
2001-10-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
15684
Status
Active
Fees Paid
Reviewed
 
Filing Details
CALCITONIN (SALMON)
Issue/Submission Date
2001-10-19
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USDMF

Found USDMF

30881
Active
DESLORELIN ACETATE
2016-10-27
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
30881
Status
Active
Fees Paid
N/A
 
Filing Details
DESLORELIN ACETATE
Issue/Submission Date
2016-10-27
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

304MF10128
Difelikefalin at 7 rue de Boulogne ...
2022-09-08
Written Confirmation

Close WC

Application Number
304MF10128
Status
 
Filing Details
Difelikefalin at 7 rue de Boulogne ...
Issue/Submission Date
2022-09-08
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USDMF

Found USDMF

18565
Active
EPTIFIBATIDE DRUG SUBSTANCE
2005-08-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
18565
Status
Active
Fees Paid
N/A
 
Filing Details
EPTIFIBATIDE DRUG SUBSTANCE
Issue/Submission Date
2005-08-01
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USDMF

Found USDMF

27714
Active
EXENDIN-4 ACETATE (EXENATIDE)
2014-01-13
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
27714
Status
Active
Fees Paid
Reviewed
 
Filing Details
EXENDIN-4 ACETATE (EXENATIDE)
Issue/Submission Date
2014-01-13
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USDMF

Found USDMF

30924
Active
EXENATIDE USP
2016-09-28
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
30924
Status
Active
Fees Paid
N/A
 
Filing Details
EXENATIDE USP
Issue/Submission Date
2016-09-28
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USDMF

Found USDMF

38184
Active
GLEPAGLUTIDE
2023-11-15
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
38184
Status
Active
Fees Paid
N/A
 
Filing Details
GLEPAGLUTIDE
Issue/Submission Date
2023-11-15
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

219MF10020
Gonadorelin acetate at 365 Maple Av...
2007-01-22
Written Confirmation

Close WC

Application Number
219MF10020
Status
 
Filing Details
Gonadorelin acetate at 365 Maple Av...
Issue/Submission Date
2007-01-22
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USDMF

Found USDMF

25021
Active
LINACLOTIDE DRUG SUBSTANCE
2011-06-01
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25021
Status
Active
Fees Paid
N/A
 
Filing Details
LINACLOTIDE DRUG SUBSTANCE
Issue/Submission Date
2011-06-01
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USDMF

Found USDMF

25025
Active
LINACLOTIDE DRUG SUBSTANCE
2011-06-07
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25025
Status
Active
Fees Paid
N/A
 
Filing Details
LINACLOTIDE DRUG SUBSTANCE
Issue/Submission Date
2011-06-07
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USDMF

Found USDMF

35860
Active
LIRAGLUTIDE
2021-06-24
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
35860
Status
Active
Fees Paid
Reviewed
 
Filing Details
LIRAGLUTIDE
Issue/Submission Date
2021-06-24
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USDMF

Found USDMF

32863
Active
OCTREOTIDE ACETATE
2018-06-18
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
32863
Status
Active
Fees Paid
Reviewed
 
Filing Details
OCTREOTIDE ACETATE
Issue/Submission Date
2018-06-18
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USDMF

Found USDMF

15096
Active
PRAMLINTIDE (ACETATE) ACTIVE PHARMA...
2000-10-16
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
15096
Status
Active
Fees Paid
N/A
 
Filing Details
PRAMLINTIDE (ACETATE) ACTIVE PHARMA...
Issue/Submission Date
2000-10-16
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USDMF

Found USDMF

15402
Active
HUMAN SECRETIN ACETATE DRUG SUBSTAN...
2001-04-25
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
15402
Status
Active
Fees Paid
N/A
 
Filing Details
HUMAN SECRETIN ACETATE DRUG SUBSTAN...
Issue/Submission Date
2001-04-25
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USDMF

Found USDMF

24451
Active
SECRETIN DRUG SUBSTANCE
2010-12-14
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
24451
Status
Active
Fees Paid
N/A
 
Filing Details
SECRETIN DRUG SUBSTANCE
Issue/Submission Date
2010-12-14
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USDMF

Found USDMF

36101
Active
SEMAGLUTIDE
2021-07-12
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
36101
Status
Active
Fees Paid
Reviewed
 
Filing Details
SEMAGLUTIDE
Issue/Submission Date
2021-07-12
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USDMF

Found USDMF

38177
Active
SEMAGLUTIDE DRUG SUBSTANCE
2023-08-02
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
38177
Status
Active
Fees Paid
Reviewed
 
Filing Details
SEMAGLUTIDE DRUG SUBSTANCE
Issue/Submission Date
2023-08-02
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USDMF

Found USDMF

34391
Active
TERLIPRESSIN ACETATE
2019-12-06
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
34391
Status
Active
Fees Paid
N/A
 
Filing Details
TERLIPRESSIN ACETATE
Issue/Submission Date
2019-12-06
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USDMF

Found USDMF

33628
Active
TERTOMOTIDE DRUG SUBSTANCE
2019-02-25
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
33628
Status
Active
Fees Paid
N/A
 
Filing Details
TERTOMOTIDE DRUG SUBSTANCE
Issue/Submission Date
2019-02-25
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USDMF

Found USDMF

16110
Active
THYMOSIN-ALPHA 1 DRUG SUBSTANCE
2002-08-22
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
16110
Status
Active
Fees Paid
N/A
 
Filing Details
THYMOSIN-ALPHA 1 DRUG SUBSTANCE
Issue/Submission Date
2002-08-22
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USDMF

Found USDMF

20478
Active
THYMOSIN-A-1, DRUG SUBSTANCE
2007-04-27
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
20478
Status
Active
Fees Paid
N/A
 
Filing Details
THYMOSIN-A-1, DRUG SUBSTANCE
Issue/Submission Date
2007-04-27
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USDMF

Caution USDMF

27577
Inactive
VASOPRESSIN
2013-12-19
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
27577
Status
Inactive
Fees Paid
N/A
 
Filing Details
VASOPRESSIN
Issue/Submission Date
2013-12-19
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USDMF

Caution USDMF

26757
Inactive
EPTIFIBATIDE
2012-12-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
26757
Status
Inactive
Fees Paid
N/A
 
Filing Details
EPTIFIBATIDE
Issue/Submission Date
2012-12-21
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USDMF

Caution USDMF

21704
Inactive
OCTREOTIDE ACETATE BY GRANULATION
2008-06-13
CEP/COS

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Japanese DMF

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Application Number
21704
Status
Inactive
Fees Paid
N/A
 
Filing Details
OCTREOTIDE ACETATE BY GRANULATION
Issue/Submission Date
2008-06-13
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USDMF

Caution USDMF

15654
Inactive
PORCINE SECRETIN, ACETATE
2001-10-05
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
15654
Status
Inactive
Fees Paid
N/A
 
Filing Details
PORCINE SECRETIN, ACETATE
Issue/Submission Date
2001-10-05
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USDMF

Caution USDMF

16615
Inactive
KL4 ACETATE (SINAPULTIDE)
2003-05-30
CEP/COS

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Japanese DMF

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Application Number
16615
Status
Inactive
Fees Paid
N/A
 
Filing Details
KL4 ACETATE (SINAPULTIDE)
Issue/Submission Date
2003-05-30
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MBI 226, A SYNTHETIC PEPTIDE

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USDMF

Caution USDMF

13146
Inactive
MBI 226, A SYNTHETIC PEPTIDE
1998-08-18
CEP/COS

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Application Number
13146
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
MBI 226, A SYNTHETIC PEPTIDE
Issue/Submission Date
1998-08-18
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SYNTHETIC PEPTIDES MPS-74, MPS-75, MPS-76, MPS-77, AND ...

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USDMF

Caution USDMF

13907
Inactive
SYNTHETIC PEPTIDES MPS-74, MPS-75, ...
1998-12-17
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
13907
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
SYNTHETIC PEPTIDES MPS-74, MPS-75, ...
Issue/Submission Date
1998-12-17
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SYNTHETIC PEPTIDE MPS-93

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USDMF

Caution USDMF

14385
Inactive
SYNTHETIC PEPTIDE MPS-93
1999-08-31
CEP/COS

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Application Number
14385
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
SYNTHETIC PEPTIDE MPS-93
Issue/Submission Date
1999-08-31
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SYNTHETIC PEPTIDE SYSTEMS MPS-116

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USDMF

Caution USDMF

15118
Inactive
SYNTHETIC PEPTIDE SYSTEMS MPS-116
2000-10-30
CEP/COS

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Written Confirmation

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Application Number
15118
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
SYNTHETIC PEPTIDE SYSTEMS MPS-116
Issue/Submission Date
2000-10-30
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MPS-69 (SYNTHETIC PEPTIDE)

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USDMF

Caution USDMF

15182
Inactive
MPS-69 (SYNTHETIC PEPTIDE)
2000-12-07
CEP/COS

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Application Number
15182
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
MPS-69 (SYNTHETIC PEPTIDE)
Issue/Submission Date
2000-12-07
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SYNTHETIC PEPTIDE MPS-178

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USDMF

Caution USDMF

16879
Inactive
SYNTHETIC PEPTIDE MPS-178
2003-09-23
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
16879
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
SYNTHETIC PEPTIDE MPS-178
Issue/Submission Date
2003-09-23
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MANUFACTURING SITE, FACILITIES, PERSONNEL AND OPERATING...

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USDMF

Caution USDMF

12517
Inactive
MANUFACTURING SITE, FACILITIES, PER...
1997-05-23
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
12517
Status
Inactive
Fees Paid
N/A
 
Filing Details
MANUFACTURING SITE, FACILITIES, PER...
Issue/Submission Date
1997-05-23
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