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01 14-PHENYLBUTYRIC ACID SODIUM SALT
02 1APRACLONIDINE HYDROCHLORIDE
03 1ARTICAINE HCL
04 1BACLOFEN
05 2CETIRIZINE DIHYDROCHLORIDE
06 1CICLOPIROX
07 1CILOSTAZOL
08 1CISATRACURIUM BESYLATE
09 1CISATRACURIUM BESYLATE PROCESS B
10 1CLASCOTERONE
11 1CLOMIPHENE CITRATE
12 1CLONIDINE BASE
13 1CLONIDINE HYDROCHLORIDE
14 1DESIPRAMINE HCL
15 1DISOPYRAMIDE PHOSPHATE
16 1DIVALPROEX SODIUM
17 1ENCLOMIPHENE CITRATE
18 1ESOMEPRAZOLE SODIUM
19 1Estetrol Monohydrate
20 1FLUTICASONE FUROATE
21 1FLUTICASONE PROPIONATE
22 1GLYCOPYRROLATE
23 1GRANISETRON BASE
24 1GRANISETRON HYDROCHLORIDE
25 1KETAMINE HYDROCHLORIDE
26 1METHIMAZOLE
27 1MIDAZOLAM
28 1MIPRI
29 1MODAFINIL
30 1MOMETASONE FUROATE
31 1MOMETASONE FUROATE MONOHYDRATE
32 1OLOPATADINE HCL
33 1OXYBUTYNIN BASE
34 1OXYBUTYNIN CHLORIDE USP
35 1PALONOSETRON HYDROCHLORIDE
36 1PERMETHRIN
37 1PODOPHYLLOTOXIN 184 NON-STERILE BULK DRUG SUBSTANCE
38 1PRAZIQUANTEL
39 1ROCURONIUM BROMIDE
40 1ROLUPERIDONE HYDROCHLORIDE
41 1ROTIGOTINE
42 1S-KETAMINE HYDROCHLORIDE
43 1SITAGLIPTIN PHOSPHATE MONOHYDRATE
44 1TAZAROTENE
45 1TIMOLOL HEMIHYDRATE
46 1TIMOLOL MALEATE
47 1TIMOLOL MALEATE (7125)
48 1TIOTROPIUM BROMIDE MONOHYDRATE
49 1TRIMEPRAZINE TARTRATE
50 1VALPROIC ACID
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01 4CU CHEMIE UETIKON GMBH
02 26PCAS
03 1POLYCARBON INDUSTRIES INC DBA PCI SYNTHESIS
04 20WAVELENGTH ENTERPRISES LTD
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01 26France
02 4Germany
03 20Israel
04 1U.S.A
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01 51Active
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01 32Complete
02 19Blank
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-12
Pay. Date : 2020-12-08
DMF Number : 9716
Submission : 1992-06-08
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16601
Submission : 2003-05-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17935
Submission : 2004-12-20
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-04
Pay. Date : 2013-09-30
DMF Number : 7077
Submission : 1987-07-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-04-05
Pay. Date : 2021-01-05
DMF Number : 35022
Submission : 2021-01-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-03-03
Pay. Date : 2017-02-08
DMF Number : 16244
Submission : 2002-11-14
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-05
Pay. Date : 2013-09-30
DMF Number : 17007
Submission : 2003-12-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16645
Submission : 2003-06-15
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-23
Pay. Date : 2017-05-09
DMF Number : 23554
Submission : 2010-02-21
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2024-03-19
Pay. Date : 2024-01-22
DMF Number : 39123
Submission : 2024-01-29
Status : Active
Type : II
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