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31 Oct 2023
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31 Oct 2023
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01 116-ALPHA-HYDROXYPREDNISOLONE
02 1ASENAPINE MALEATE
03 1AZATHIOPRINE
04 1AZATHIOPRINE (PROCESS 3)
05 1BACLOFEN
06 1BACLOFEN (PROCESS 2)
07 1BENZTROPINE MESYLATE
08 1BUDESONIDE
09 1BUPRENORPHINE HYDROCHLORIDE
10 1CONJUGATED ESTROGENS TYPE CN
11 1DANAPAROID SODIUM
12 1DESMOPRESSIN
13 1DESOGESTREL
14 1EPTIFIBATIDE
15 1ESTRADIOL
16 1ESTRADIOL 3-ACETATE
17 1ESTRADIOL VALERATE
18 1ESTRIOL
19 1ETHINYL ESTRADIOL
20 1ETHYNODIOL DIACETATE
21 1ETONOGESTREL
22 1FLUPHENAZINE DECANOATE
23 1FLUPHENAZINE HYDROCHLORIDE
24 1FONDAPARINUX SODIUM USP
25 1GANIRELIX
26 1GONADERELIN DIACETATE TETRAHYDRATE
27 1GONADORELIN ACETATE
28 1HEPARIN SODIUM
29 1HEPARIN SODIUM CRUDE (PORCINE)
30 1HEPARIN SODIUM PORCINE
31 1HEPARIN SODIUM USP
32 1HUMAN CHORIONIC GONADOTROPHIN (HCG)
33 1HYDROXYPROGESTERONE CAPROATE
34 1LEUPRORELIN HIGHLY PURIFIED
35 1LEVALBUTEROL HYDROCHLORIDE
36 1METHAZOLAMIDE
37 1METHYLTESTOSTERONE
38 1MIRTAZAPINE
39 1NALOXONE HYDROCHLORIDE
40 1NALTREXONE HYDROCHLORIDE
41 1NANDROLONE DECANOATE
42 1NORETHINDRONE
43 1NORETHINDRONE ACETATE
44 1OXYTOCIN
45 1PENBUTOLOL SULFATE
46 1PROGESTERONE
47 1REMIFENTANIL HYDROCHLORIDE
48 1RIMEXOLONE
49 1ROCURONIUM BROMIDE
50 1ROPIVACAINE
51 1ROPIVACAINE HYDROCHLORIDE
52 1SCOPOLAMINE (HYOSCINE)
53 1TESTOSTERONE
54 1TESTOSTERONE CYPIONATE
55 1TESTOSTERONE ENANTHATE
56 1TESTOSTERONE UNDECANOATE
57 1TETRACOSACTIDE
58 1THIOTHIXENE
59 1VECURONIUM BROMIDE
60 1VINCRISTINE SULPHATE/VINBLASTINE SULPHATE
01 40ASPEN OSS BV
02 3BIOCHEM OSS BV
03 1BIOCHEM SIOUX CITY INC
04 16FINE CHEMICALS CORP PTY LTD
01 44Netherlands
02 16South Africa
01 56Active
02 4Inactive
01 28Complete
02 32Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8855
Submission : 1990-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34868
Submission : 2020-06-10
Status : Active
Type : II