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01 14-PHENYLBUTYRIC ACID SODIUM SALT
02 1AMMONIUM LACTATE
03 1APRACLONIDINE HYDROCHLORIDE
04 1ARTICAINE HCL
05 1BACLOFEN
06 2CETIRIZINE DIHYDROCHLORIDE
07 1CICLOPIROX
08 1CILOSTAZOL
09 1CISATRACURIUM BESYLATE
10 1CISATRACURIUM BESYLATE PROCESS B
11 1CLASCOTERONE
12 1CLOMIPHENE CITRATE
13 1CLONIDINE BASE
14 1CLONIDINE HYDROCHLORIDE
15 1DESIPRAMINE HCL
16 1DISOPYRAMIDE PHOSPHATE
17 1DIVALPROEX SODIUM
18 1ENCLOMIPHENE CITRATE
19 1ESOMEPRAZOLE SODIUM
20 1Estetrol Monohydrate
21 1FENOFIBRATE
22 1FLUTICASONE FUROATE
23 1FLUTICASONE PROPIONATE
24 1GLYCOPYRROLATE
25 1GRANISETRON BASE
26 1GRANISETRON HYDROCHLORIDE
27 1KETAMINE HYDROCHLORIDE
28 1MEPIVACAINE HYDROCHLORIDE
29 1METHIMAZOLE
30 1MIDAZOLAM
31 1MIPRI
32 1MODAFINIL
33 1MOMETASONE FUROATE
34 1MOMETASONE FUROATE MONOHYDRATE
35 1OLOPATADINE HCL
36 1OXYBUTYNIN BASE
37 1OXYBUTYNIN CHLORIDE USP
38 1PALONOSETRON HYDROCHLORIDE
39 1PERMETHRIN
40 1PODOPHYLLOTOXIN 184 NON-STERILE BULK DRUG SUBSTANCE
41 1PRAZIQUANTEL
42 1ROCURONIUM BROMIDE
43 1ROLUPERIDONE HYDROCHLORIDE
44 1ROTIGOTINE
45 1S-KETAMINE HYDROCHLORIDE
46 1SITAGLIPTIN PHOSPHATE MONOHYDRATE
47 1TAZAROTENE
48 1TIMOLOL HEMIHYDRATE
49 1TIMOLOL MALEATE
50 1TIMOLOL MALEATE (7125)
51 1TIOTROPIUM BROMIDE MONOHYDRATE
52 1TRIMEPRAZINE TARTRATE
53 1VALPROIC ACID
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01 4CU CHEMIE UETIKON GMBH
02 27PCAS
03 1POLYCARBON INDUSTRIES INC DBA PCI SYNTHESIS
04 22WAVELENGTH ENTERPRISES LTD
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01 27France
02 4Germany
03 22Israel
04 1U.S.A
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01 54Active
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01 33Complete
02 21Blank
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 : Complete
Rev. Date : 2023-11-02
Pay. Date : 2023-10-30
DMF Number : 12003
Submission : 1996-06-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16601
Submission : 2003-05-21
Status : Active
Type : II