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11 May 2013
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01 1ACEBUTOLOL HYDROCHLORIDE USP
02 1ALOSETRON HYDROCHLORIDE
03 1ATOVAQUONE USP
04 1ATROPINE SULFATE MONOHYDRATE USP
05 1BENAZEPRIL HYDROCHLORIDE USP
06 1BETAINE ANHYDROUS
07 1CARGLUMIC ACID
08 1CEVIMELINE HYDROCHLORIDE USP
09 1CHLORZOXAZONE USP
10 1DAPSONE USP
11 1DIAZOXIDE USP
12 1DICHLORPHENAMIDE USP
13 1ESTAZOLAM USP
14 1FERRIC CITRATE
15 1FLUDROCORTISONE ACETATE USP
16 1GLYCEROL PHENYLBUTYRATE
17 1KETOCONAZOLE USP
18 1L-GLUTAMINE USP
19 1LEVOCARNITINE USP
20 1LEVOKETOCONAZOLE
21 1LEVORPHANOL TARTRATE USP
22 1METHENAMINE HIPPURATE
23 1METHSUXIMIDE USP
24 1METHYLTESTOSTERONE USP
25 1NITISINONE
26 1OXANDROLONE USP
27 1PHENOXYBENZAMINE HYDROCHLORIDE USP
28 1PITOLISANT HYDROCHLORIDE
29 1PITOLISANT HYDROCHLORIDE SD
30 1PRAZOSIN HYDROCHLORIDE USP
31 1PRUCALOPRIDE SUCCINATE
32 1RAMELTEON
33 1SODIUM PHENYLBUTYRATE USP
34 1STIRIPENTOL
35 1TAFAMIDIS
36 1TAFAMIDIS (CC)
37 1TAFAMIDIS MEGLUMINE
38 1THIOTHIXENE USP
39 1TRANYLCYPROMINE SULFATE USP
40 1TREPROSTINIL DIOLAMINE
41 1TREPROSTINIL SODIUM
42 1TRIENTINE HYDROCHLORIDE USP
43 1TRIENTINE TETRAHYDROCHLORIDE
44 1TRIHEPTANOIN
45 1ß-NICOTINAMIDE ADENINE DINUCLEOTIDE
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01 12NOVITIUM PHARMA LLC
02 5NURAY CHEMICALS PRIVATE LTD
03 3NURAY CHEMICALS PVT LTD
04 25SS PHARMA LLC
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01 22India
02 23U.S.A
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01 45Active
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01 42Complete
02 3Blank
GDUFA
DMF Review : Complete
Rev. Date : 2021-06-16
Pay. Date : 2021-04-30
DMF Number : 35857
Submission : 2021-04-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-10-19
Pay. Date : 2013-09-12
DMF Number : 27378
Submission : 2013-09-16
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36339
Submission : 2021-10-11
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-25
Pay. Date : 2019-06-25
DMF Number : 33781
Submission : 2019-08-08
Status : Active
Type : II