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 5Accord healthcare
04 2Aspiro Pharma
05 1Aurobindo Pharma Limited
06 5Baxter Healthcare Corporation
07 1Biocon
08 4Biological E
09 4CUBIST PHARMS INC
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 1Kaliberr Labs
21 2Labatec Pharm
22 2Maia Pharmaceuticals
23 2Meitheal Pharmaceuticals
24 6Merck & Co
25 2Olon S.p.A
26 1Qilu Pharmaceutical
27 2Sagent Pharmaceuticals
28 1Sandoz B2B
29 1Teva Pharmaceutical Industries
30 2Viatris
31 3Xellia Pharmaceuticals ApS
32 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 1INF
06 1INJ
07 6Injection
08 2Lyophilizate
09 2Lyophilized Injection
10 4POWDER FOR SOLUTION
11 38POWDER;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 5Generic
04 2Lead Market Dossiers- Filed
05 1Originator
06 36RX
07 25Blank
01 2CUBICIN
02 2CUBICIN RF
03 6Cubicin
04 34DAPTOMYCIN
05 3DAPTOMYCIN FOR INJECTION
06 4DAPTOMYCIN IN 0.9% SODIUM CHLORIDE
07 1DAPZURA RT
08 2Daptomycin Accord
09 2Daptomycin Labatec
10 1Drymred 500
11 18Blank
01 4Canada
02 3China
03 2Denmark
04 7India
05 4Italy
06 1Norway
07 2South 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
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 : 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 : RX
Registration Country : USA
Brand Name : DAPTOMYCIN
Dosage Form : POWDER;INTRAVENOUS
Dosage Strength : 350MG/VIAL
Packaging :
Approval Date : 2019-07-12
Application Number : 212667
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 : 2021-09-02
Application Number : 213171
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : DAPZURA RT
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 : 2022-01-25
Application Number : 213645
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 : 2019-06-26
Application Number : 212513
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 : 2020-08-20
Application Number : 213425
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 : 2024-08-01
Application Number : 213396
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 : 2021-06-29
Application Number : 213623
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 : 500MG/VIAL
Packaging :
Approval Date : 2021-04-21
Application Number : 212250
Regulatory Info : RX
Registration Country : USA
