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01 15-AMINOLEVULINIC ACID HYDROCHLORIDE
02 1AC-137
03 1ACT1 ACETATE
04 1BIVALIRUDIN
05 1CARBIDOPA
06 1DESMOPRESSIN ACETATE
07 1ETOMIDATE
08 1ETOMIDATE PROCESS B
09 1EXENATIDE (BULK)
10 1GLUCAGON
11 1GLUCAGON PHARMA GRADE
12 1GONADORELIN ACETATE
13 2GOSERELIN ACETATE
14 1HISTRELIN ACETATE
15 1ICATIBANT ACETATE
16 1LANREOTIDE ACETATE
17 1LEUPROLIDE ACETATE
18 1LIRAGLUTIDE
19 1LIRAGLUTIDE DRUG SUBSTANCE
20 1LUM015 ACETATE
21 1OCTREOTIDE ACETATE
22 1OCTREOTIDE ACETATE USP
23 1OCTREOTIDE HYDROCHLORIDE
24 1OVINE CORTICOTROPIN RELEASING FACTOR (0CRF)
25 1PARATHYROID HORMONE (1-34) HUMAN
26 1PROPOFOL
27 1SALMON CALCITONIN (SCT)
28 1SEMAGLUTIDE
29 1SINCALIDE
30 1TETRACOSACTIDE
31 1TRIPTORELIN PAMOATE
32 1VASOACTIVE INTESTINAL PEPTIDE (VIP), HUMAN
33 1VASOPRESSIN, USP (BULK)
34 1ZP4207
35 1[N-TRANS-3-HEXENOYL] GRF (1-44), ACETATE (BULK)
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01 17BACHEM AG
02 14BACHEM AMERICAS INC
03 5BACHEM SA
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01 34Switzerland
02 2U.S.A
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01 35Active
02 1Inactive
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01 17Complete
02 19Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9972
Submission : 1992-11-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10068
Submission : 1993-02-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31458
Submission : 2017-03-31
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-07-11
Pay. Date : 2013-06-17
DMF Number : 9231
Submission : 1991-07-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-31
Pay. Date : 2014-03-27
DMF Number : 9951
Submission : 1992-11-05
Status : Active
Type : II