DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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01 3Dr. Reddy's Laboratories
02 1NanoAlvand
03 2Accord healthcare
04 1Aurobindo Pharma Limited
05 1Chemi SpA
06 1Cipla
07 1Clinigen Group
08 1GLAND PHARMA LIMITED
09 1GetWell Pharmaceutical
10 1HETERO LABS LTD VI
11 1Hainan Poly Pharm
12 1Hansoh Pharma
13 1Hetero Drugs
14 4Janssen-Cilag
15 1Johnson & Johnson Innovative Medicine
16 1Lupin Ltd
17 1MSN Laboratories
18 1Meitheal Pharmaceuticals
19 1Nivagen
20 1Novast Laboratories
21 1Otsuka Chemical Co Ltd
22 1PENDOPHARM DIVISION OF DE PHARMASCIENCE INC
23 1Pharmascience Inc.
24 1Qilu Pharmaceutical
25 1Sagent Pharmaceuticals
26 1Sakar Healthcare
27 2Samyang Biopharmaceuticals
28 2Sandoz B2B
29 1Sun Pharmaceutical Industries Limited
30 2Taiho Pharmaceutical
31 1TherDose Pharma
32 1Wockhardt
33 1Zydus Pharmaceuticals
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01 1Decitabina 50Mg 20Ml 1 Units Parenteral Use
02 3Dry Sub
03 20INJECTABLE;INTRAVENOUS
04 5Injection
05 2Lyophilized Injection
06 3POI
07 1POWDER
08 1POWDER FOR CONCENTRATE FOR
09 1POWDER;INTRAVENOUS
10 1Powder
11 1Powder to concentrate to the infusion fluid, resolution
12 1TABLET
13 1TABLET;ORAL
14 1Vial
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01 2DISCN
02 2Generic
03 1Lead Market Dossiers- Approved in US
04 1Lead Market Dossiers- Filed
05 1Originator
06 2Prescription
07 20RX
08 13Blank
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01 2DACOGEN
02 2DECILID
03 1DECIMA
04 20DECITABINE
05 1DECITOTHER
06 1DEMYLOCAN
07 4Dacogen
08 1Deceq
09 1Decitabin Accord
10 1Decitabin Sandoz
11 1Elodyst
12 2INQOVI
13 1Tabinoz
14 4Blank
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01 2Canada
02 1China
03 5India
04 1Iran
05 1Italy
06 1Norway
07 3South Africa
08 2South Korea
09 1Sweden
10 3Switzerland
11 22USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2013-07-11
Application Number : 203131
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Iran
Brand Name : Tabinoz
Dosage Form : Vial
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Filed
Registration Country : India
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Lead Market Dossiers- Approved in US
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date :
Application Number :
Regulatory Info : Lead Market Dossiers- Approved in US
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2017-02-27
Application Number : 203475
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2021-09-20
Application Number : 214569
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2017-09-22
Application Number : 206033
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2017-11-16
Application Number : 208601
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2020-11-23
Application Number : 205539
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : China
Brand Name :
Dosage Form : Injection
Dosage Strength : 50MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : China
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2022-04-15
Application Number : 213472
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Sweden
Brand Name : DACOGEN
Dosage Form : POWDER FOR CONCENTRATE FOR
Dosage Strength : 50 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Dacogen
Dosage Form : Decitabina 50Mg 20Ml 1 Units Parenteral Use
Dosage Strength : 1 vial EV 50 mg 20 ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Brand Name : Dacogen
Dosage Form : Powder to concentrate to the infusion fluid, resolution
Dosage Strength : 50 mg
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2018-11-09
Application Number : 210756
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2021-07-02
Application Number : 212959
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2019-08-28
Application Number : 212265
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2020-12-07
Application Number : 212117
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2019-09-16
Application Number : 210984
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : DACOGEN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2006-05-02
Application Number : 21790
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2017-05-31
Application Number : 204607
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2021-04-12
Application Number : 212826
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2018-03-16
Application Number : 207100
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : South Korea
Brand Name : DECILID
Dosage Form : Lyophilized Injection
Dosage Strength : 40MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : South Korea
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2014-08-28
Application Number : 202969
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2014-01-28
Application Number : 205582
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : INQOVI
Dosage Form : TABLET;ORAL
Dosage Strength : 100MG;35MG
Packaging :
Approval Date : 2020-07-07
Application Number : 212576
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2019-04-09
Application Number : 209056
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2021-11-19
Application Number : 214486
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DECITABINE
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 50MG/VIAL
Packaging :
Approval Date : 2024-05-10
Application Number : 215355
Regulatory Info : RX
Registration Country : USA
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