DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 4Dr. Reddy's Laboratories
02 6Accord healthcare
03 2Aspiro Pharma
04 1Aurobindo Pharma Limited
05 5Baxter Healthcare Corporation
06 1Biocon
07 4Biological E
08 4CUBIST PHARMS INC
09 1Clinigen Group
10 1DR REDDY'S LABORATORIES LTD
11 2Deva Holding AS
12 1Dr Reddy's Laboratories (Pty) Ltd
13 2Fresenius Kabi USA
14 3Hainan Poly Pharm
15 1Hangzhou Zhongmei Huadong Pharmaceutical
16 2Health Biotech
17 3Hikma Pharmaceuticals
18 4Hospira, Inc.
19 2Jiangsu Hengrui Medicine
20 1Kahma Group
21 1Kaliberr Labs
22 2Labatec Pharm
23 1Macleods Pharmaceuticals Limited
24 2Maia Pharmaceuticals
25 2Medichem S.A
26 2Meitheal Pharmaceuticals
27 6Merck & Co
28 2Olon S.p.A
29 1Pharma Dynamics
30 1Qilu Pharmaceutical
31 2Sagent Pharmaceuticals
32 1Sandoz B2B
33 1Teva Pharmaceutical Industries
34 2Viatris
35 3Xellia Pharmaceuticals ApS
36 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 6Dry Sub
05 5INF
06 1INJ
07 6Injection
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 4Vial
01 1Available Dossier- US-EU-RoW
02 8DISCN
03 10Generic
04 2Lead Market Dossiers- Filed
05 1Originator
06 33RX
07 25Blank
01 1CUBACT
02 2CUBICIN
03 2CUBICIN RF
04 6Cubicin
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 1Daptomycin Equity
14 2Daptomycin Labatec
15 1Drymred 500
16 18Blank
01 4Canada
02 3China
03 2Denmark
04 7India
05 4Italy
06 1Norway
07 7South Africa
08 2Spain
09 6Switzerland
10 2Turkey
11 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
Regulatory Info : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 500MG/VIAL
Packaging :
Approval Date : 2019-06-24
Application Number : 211961
Regulatory Info : RX
Registration Country : USA
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 : 2019-08-22
Application Number : 212022
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
