01 2Cetostearyl Alcohol
02 1Cetyl Alcohol
03 2Cetyl Palmitate
04 1Cocoyl Caprylocaprate
05 1Copovidone
06 1Crospovidone
07 1Decyl Oleate
08 1Glyceryl Monostearate
09 1Hydrogenated Castor Oil
10 1Isopropyl Myristate
11 1Lactose
12 1Macrogol 15 Hydroxystearate
13 1Mannitol
14 1Medium Chain Triglycerides Excipient
15 3Methacrylic Acid - Ethyl Acrylate Copolymer
16 1Methyl Methacrylate
17 1Octyldodecanol
18 1Oleyl Alcohol
19 1PEG-25 Hydrogenated Castor Oil
20 1Palmitic Acid
21 1Poloxamer 188
22 1Polyethylene Glycol Excipient
23 1Polyoxyl 20 Cetostearyl Ether
24 1Polyoxyl 40 Hydrogenated Castor Oil
25 2Polyvinyl Acetate
26 2Polyvinyl Alcohol Graft Polyethylene Glycol Copolymer
27 1Polyvinyl Caprolactam
28 4Povidone
29 1Povidone API
30 2Sodium Lauryl Sulfate
31 1Solutol Hs 15
32 1Stearic Acid
33 1Stearyl Alcohol
34 1Vitamin E TPGS Excipient
35 10Blank
01 40Active
02 11Inactive
03 3Blank
01 5Valid
02 1Withdrawn by Holder
03 48Blank
01 54Blank
01 54Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2855
Submission : 1977-02-08
Status : Active
Type : IV
Certificate Number : R1-CEP 2007-076 - Rev 01
Issue Date : 2015-06-26
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32695
Submission : 2018-03-27
Status : Active
Type : IV
Certificate Number : R1-CEP 2007-077 - Rev 02
Issue Date : 2017-01-30
Type :
Substance Number :
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
