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01 1Alogliptin Benzoate
02 1Articaine Hydrochloride
03 1Atazanavir Sulfate
04 1Benznidazole
05 1Bromazepam
06 1Budesonide
07 1Bupivacaine
08 1Bupivacaine Hydrochloride
09 1Cholestyramine
10 1Clonazepam
11 1Dapagliflozin
12 1Diazepam
13 1Diclofenac
14 1Diclofenac Diethylamine
15 1Diclofenac Potassium
16 1Diclofenac Sodium
17 1Diethylcarbamazine Citrate
18 1Edoxaban Tosylate
19 1Efavirenz
20 1Empagliflozin
21 1Emtricitabine
22 1Ephedrine Sulfate
23 1Esketamine Hydrochloride
24 1Flurazepam Monohydrochloride
25 1Galantamine Hydrobromide
26 1Haloperidol
27 1Indomethacin
28 1Isometheptene Mucate
29 1Isometheptene hydrochloride
30 1Lamivudine
31 1Lidocaine
32 1Lidocaine Hydrochloride
33 1Linagliptin
34 1Mepivacaine Hydrochloride
35 1Midazolam
36 1Midazolam Hydrochloride
37 1Midazolam Maleate
38 1Mycophenolate Sodium
39 1Olanzapine
40 1Olanzapine Pamoate
41 1Olanzapine Tartrate
42 1Orphenadrine
43 1Oxymetazoline Hydrochloride
44 1Phenylephrine Hydrochloride
45 1Phenytoin
46 1Pramipexole Dihydrochloride
47 1Prilocaine
48 1Prilocaine Hydrochloride
49 1Pseudoephedrine Hydrochloride
50 1Pseudoephedrine Sulfate
51 1Quetiapine Hemifumarate
52 1Rivaroxaban
53 1Sodium Formaldehyde Sulfoxylate
54 1Spironolactone
55 1Tenofovir Disoproxil Fumarate
56 1Thiabendazole
57 1Vortioxetine Hydrobromide
58 1Zidovudine
59 1Zolpidem Tartrate
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01 4Active
02 55Blank
01 1Valid
02 58Blank
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01 59Blank
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01 59Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-15
Pay. Date : 2017-12-06
DMF Number : 32283
Submission : 2017-12-07
Status : Active
Type : II
Certificate Number : R0-CEP 2019-135 - Rev 00
Issue Date : 2021-04-06
Type : Chemical
Substance Number : 1362
Status : Valid
NDC Package Code : 59014-0052
Start Marketing Date : 2017-09-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-03-25
Pay. Date : 2018-11-13
DMF Number : 33285
Submission : 2018-11-21
Status : Active
Type : II
NDC Package Code : 59014-0053
Start Marketing Date : 2018-04-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-02-22
Pay. Date : 2023-01-31
DMF Number : 37647
Submission : 2022-12-09
Status : Active
Type : II
NDC Package Code : 59014-0020
Start Marketing Date : 2022-11-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others