DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 6Dr. Reddy's Laboratories
02 10Accord healthcare
03 2Aspiro Pharma
04 1Aurobindo Pharma Limited
05 5Baxter Healthcare Corporation
06 2Be Pharma B.V.
07 1Biocon
08 4Biological E
09 4CUBIST PHARMS INC
10 1Clinigen Group
11 1DR REDDY'S LABORATORIES LTD
12 2Deva Holding AS
13 1Dr Reddy's Laboratories (Pty) Ltd
14 2Fresenius Kabi USA
15 3Hainan Poly Pharm
16 1Hameln Pharma GmbH
17 1Hangzhou Zhongmei Huadong Pharmaceutical
18 2Health Biotech
19 5Hikma Pharmaceuticals
20 4Hospira, Inc.
21 2Jiangsu Hengrui Medicine
22 1Kahma Group
23 1Kaliberr Labs
24 2Labatec Pharm
25 2MIP Pharma
26 2MSD Pharmaceuticals
27 1Macleods Pharmaceuticals Limited
28 2Maia Pharmaceuticals
29 2Medichem S.A
30 2Meitheal Pharmaceuticals
31 6Merck & Co
32 2Noridem Enterprises Ltd
33 2Olon S.p.A
34 2Pfizer Inc
35 1Pharma Dynamics
36 1Qilu Pharmaceutical
37 2Sagent Pharmaceuticals
38 1Sandoz B2B
39 1Teva Pharmaceutical Industries
40 2Viatris
41 3Xellia Pharmaceuticals ApS
42 1Zhejiang Hisun Pharmaceutical
01 2 Powder for Solution (Lyophilized Powder)
02 1Daptomycin 350Mg 1 Unit Parenteral Use
03 1Daptomycin 500Mg 10Ml 1 Units Parenteral Use
04 5INF
05 1INJ
06 6Injection
07 21Injection/Infusion Solution
08 2Lyophilizate
09 2Lyophilized Injection
10 1POI
11 4POWDER FOR SOLUTION
12 38POWDER;INTRAVENOUS
13 2Powder for Injection
14 1Powder for injection/infusion fluid, resolution
15 4SOLUTION;INTRAVENOUS
16 4Solution For Injection
17 4Vial
01 6Allowed
02 19Approved
03 1Available Dossier- US-EU-RoW
04 8DISCN
05 10Generic
06 2Lead Market Dossiers- Filed
07 1Originator
08 33RX
09 19Blank
01 1CUBACT
02 2CUBICIN
03 2CUBICIN RF
04 8Cubicin
05 1Cusyn
06 1DABUCOR 500
07 34DAPTOMYCIN
08 3DAPTOMYCIN FOR INJECTION
09 4DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
10 1DAPZURA RT
11 1Dapicub
12 2Daptomycin Accord
13 2Daptomycin Accord Healthcare
14 2Daptomycin Accordpharma
15 2Daptomycin Be Pharma
16 1Daptomycin Equity
17 1Daptomycin Hameln
18 2Daptomycin Hikma
19 2Daptomycin Hospira
20 2Daptomycin Labatec
21 2Daptomycin Mip
22 2Daptomycin Noridem
23 2Daptomycin Reddy
24 1Drymred 500
25 18Blank
01 4Canada
02 3China
03 2Denmark
04 7India
05 4Italy
06 1Norway
07 7South Africa
08 2Spain
09 19Sweden
10 6Switzerland
11 2Turkey
12 42USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2019-05-01
Application Number : 208375
Regulatory Info : RX
Registration Country : USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 350MG/VIAL
Packaging :
Approval Date : 2020-08-31
Application Number : 211403
Regulatory Info : RX
Registration Country : USA
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 : 350MG
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- Filed
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 500MG
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 : Approved
Registration Country : Sweden
Brand Name : Daptomycin Reddy
Dosage Form : Injection/Infusion Solution
Dosage Strength : 350mg
Packaging :
Approval Date : 12/09/2017
Application Number : 20160601000022
Regulatory Info : Approved
Registration Country : Sweden
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Daptomycin Reddy
Dosage Form : Injection/Infusion Solution
Dosage Strength : 500mg
Packaging :
Approval Date : 12/09/2017
Application Number : 20160601000039
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CUBICIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 250MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2003-09-12
Application Number : 21572
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CUBICIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2003-09-12
Application Number : 21572
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : CUBICIN RF
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 500MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2016-07-06
Application Number : 21572
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2018-04-11
Application Number : 206077
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 350MG/VIAL
Packaging :
Approval Date : 2017-10-20
Application Number : 209949
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2014-09-12
Application Number : 202857
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 350MG/VIAL
Packaging :
Approval Date :
Application Number : 203797
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 350MG/VIAL
Packaging :
Approval Date : 2021-06-21
Application Number : 210282
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2021-06-21
Application Number : 210282
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2019-11-15
Application Number : 207104
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 350MG/VIAL
Packaging :
Approval Date : 2017-09-12
Application Number : 208385
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2016-03-25
Application Number : 91039
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2018-06-05
Application Number : 205037
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2016-06-15
Application Number : 206005
Regulatory Info : RX
Registration Country : USA
