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01 1Abemaciclib
02 1Alimemazine
03 1Ammonium Lactate
04 1Apraclonidine Hydrochloride
05 1Articaine Hydrochloride
06 1Baclofen
07 2Cetirizine Dihydrochloride
08 1Ciclopirox
09 1Ciclopirox Olamine
10 1Cilostazol
11 3Cisatracurium Besylate
12 2Clascoterone
13 2Clomiphene Citrate
14 2Clonidine
15 1Desipramine Hydrochloride
16 1Disopyramide
17 2Divalproex Sodium
18 1Dorzolamide Hydrochloride
19 1Esketamine Hydrochloride
20 1Esomeprazole Magnesium
21 1Esomeprazole Sodium
22 1Estetrol
23 1Etripamil
24 1Fenofibrate
25 1Flumazenil
26 1Fluralaner
27 1Fluticasone Furoate
28 1Fluticasone Propionate
29 1Glycopyrronium Bromide
30 1Granisetron
31 1Granisetron Hydrochloride
32 1Heptaminol
33 1Ketamine Hydrochloride
34 1Mepivacaine Hydrochloride
35 1Mequitazine
36 1Methimazole
37 1Midazolam
38 1Mifepristone
39 1Modafinil
40 2Mometasone Furoate
41 1Moxonidine
42 1Oclacitinib Maleate
43 1Olopatadine Hydrochloride
44 1Oxeladin
45 1Oxybutynin
46 2Oxybutynin Hydrochloride
47 1Palonosetron
48 1Paracetamol
49 1Permethrin
50 1Pholcodine
51 1Pindolol
52 1Piperidolate Hydrochloride
53 1Podophyllotoxin
54 1Praziquantel
55 1Promazine
56 1Propofol
57 1R-Ketamine
58 1Racecadotril
59 1Remimazolam Besylate
60 1Resmetirom
61 1Rocuronium Bromide
62 1Roluperidone
63 1Rotigotine
64 2Sitagliptin Phosphate
65 1Sodium Phenylacetate
66 1Sodium Phenylbutyrate
67 1Sparsentan
68 1Tamoxifen Citrate
69 1Tazarotene
70 1Tetrahydrozoline
71 4Timolol Maleate
72 1Tiotropium Bromide
73 1Troxerutin
74 1Vamorolone
75 1Varenicline Tartrate
76 1Blank
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01 54Active
02 35Blank
01 39Valid
02 1Withdrawn by Holder
03 49Blank
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01 1218MF10148
02 1218MF10150
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04 1218MF10293
05 1218MF10296
06 1218MF10399
07 1218MF10400
08 1218MF10834
09 1218MF10980
10 1218MF11004
11 1219MF10315
12 1220MF10040
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20 70Blank
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01 89Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15817
Submission : 2002-01-17
Status : Active
Type : II
Certificate Number : R1-CEP 2015-165 - Rev 00
Issue Date : 2021-06-08
Type : Chemical