DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 3Dr. Reddy's Laboratories
02 1NanoAlvand
03 2Accord healthcare
04 1Aurobindo Pharma Limited
05 1Chemi SpA
06 1Cipla
07 1GLAND PHARMA LIMITED
08 1GetWell Pharmaceutical
09 1HETERO LABS LTD VI
10 1Hainan Poly Pharm
11 1Hansoh Pharma
12 4Janssen-Cilag
13 1Johnson & Johnson Innovative Medicine
14 1Lupin Ltd
15 1MSN Laboratories
16 1Meitheal Pharmaceuticals
17 1Nivagen
18 1Novast Laboratories
19 2Otsuka Chemical Co Ltd
20 1PENDOPHARM DIVISION OF DE PHARMASCIENCE INC
21 1Pharmascience Inc.
22 1Qilu Pharmaceutical
23 1Sagent Pharmaceuticals
24 1Sakar Healthcare
25 2Samyang Biopharmaceuticals
26 2Sandoz B2B
27 1Sun Pharmaceutical Industries Limited
28 1Taiho Pharmaceutical
29 1TherDose Pharma
30 1Wockhardt
31 1Zydus Pharmaceuticals
01 1Decitabina 50Mg 20Ml 1 Units Parenteral Use
02 3Dry Sub
03 20INJECTABLE;INTRAVENOUS
04 5Injection
05 2Lyophilized Injection
06 1POI
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
01 2DISCN
02 1Lead Market Dossiers- Approved in US
03 1Lead Market Dossiers- Filed
04 1Originator
05 20RX
06 15Blank
01 2DACOGEN
02 2DECILID
03 1DECIMA
04 20DECITABINE
05 1DECITOTHER
06 1DEMYLOCAN
07 4Dacogen
08 1Decitabin Accord
09 1Decitabin Sandoz
10 2INQOVI
11 1Tabinoz
12 4Blank
01 2Canada
02 1China
03 5India
04 1Iran
05 1Italy
06 1Norway
07 1South 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 : 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 : 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 : 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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