DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 4Dr. Reddy's Laboratories
02 2Medichem S.A
03 1ABEX Pharmaceutica
04 5Accord healthcare
05 2Aspiro Pharma
06 1Aurobindo Pharma Limited
07 5Baxter Healthcare Corporation
08 1Biocon
09 4Biological E
10 4CUBIST PHARMS INC
11 1Clinigen Group
12 1DR REDDY'S LABORATORIES LTD
13 2Deva Holding AS
14 1Dr Reddy's Laboratories (Pty) Ltd
15 2Fresenius Kabi USA
16 3Hainan Poly Pharm
17 1Hangzhou Zhongmei Huadong Pharmaceutical
18 2Health Biotech
19 4Hospira, Inc.
20 2Jiangsu Hengrui Medicine
21 1Kahma Group
22 1Kaliberr Labs
23 2Labatec Pharm
24 2Meitheal Pharmaceuticals
25 6Merck & Co
26 2Olon S.p.A
27 1Pharma Dynamics
28 1Qilu Pharmaceutical
29 2Sagent Pharmaceuticals
30 1Sandoz B2B
31 1Teva Pharmaceutical Industries
32 2Viatris
33 6Xellia Pharmaceuticals ApS
34 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 4POWDER FOR SOLUTION
11 36POWDER;INTRAVENOUS
12 2Powder for Injection
13 1Powder for injection/infusion fluid, resolution
14 4SOLUTION;INTRAVENOUS
15 4Vial
01 1Available Dossier- US-EU-RoW
02 5DISCN
03 9Generic
04 2Lead Market Dossiers- Filed
05 1Originator
06 4Prescription
07 34RX
08 21Blank
01 1CUBACT
02 2CUBICIN
03 2CUBICIN RF
04 6Cubicin
05 1Cusyn
06 32DAPTOMYCIN
07 3DAPTOMYCIN FOR INJECTION
08 4DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
09 1DAPZURA RT
10 1Dapicub
11 2Daptomycin Accord
12 1Daptomycin Equity
13 2Daptomycin Labatec
14 1Drymred 500
15 18Blank
01 4Canada
02 3China
03 2Denmark
04 7India
05 4Italy
06 1Norway
07 6South Africa
08 2Spain
09 6Switzerland
10 2Turkey
11 40USA
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
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Powder for Injection
Dosage Strength : 350MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
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
Medichem is a vertically integrated pharmaceutical company specializing in the development & manufacturing of APIs & FDFs.
Regulatory Info :
Registration Country : Spain
Brand Name :
Dosage Form : Powder for Injection
Dosage Strength : 500MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Spain
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 : 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
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
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