DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 1Dr. Reddy's Laboratories
02 1AVIR PHARMA INC.
03 3Accord healthcare
04 1Apotex Inc
05 1Arrotex Pharmaceuticals
06 1Aurobindo Pharma Limited
07 2Baxter Healthcare Corporation
08 2Cipla
09 1FORMATIVE PHARMA INC.
10 1Flagship Biotech International Pvt. Ltd
11 1Fresenius Kabi Austria
12 1Fresenius Kabi USA
13 1Hainan Poly Pharm
14 1Hainan Shuangcheng Pharmaceuticals
15 2Hospira, Inc.
16 1JUNO PHARMACEUTICALS CORP.
17 1Jodas Expoim Pvt. Ltd
18 1LABORATORIO REIG JOFRE SA
19 1Maia Pharmaceuticals
20 1Meitheal Pharmaceuticals
21 1Pliva Hrvatska
22 1Reig Jofre
23 2Sandoz B2B
24 1Slate Run Pharmaceuticals
25 1Stanex Drugs and Chemicals
26 1THE MEDICINES COMPANY UK LTD
27 2The Medic Ines Company UK Ltd
28 1The Medicines Company
29 2Viatris
01 1Bivalirudin 250Mg 10 Units Parenteral Use
02 1INJECTABLE;INJECTION
03 13INJECTABLE;INTRAVENOUS
04 3Injection
05 4Injection/Infusion Solution
06 1Lyo.Inj
07 4POWDER FOR SOLUTION
08 1Powder For Concentrate For Injectable Solution And For Infusion
09 1Powder For Concentrate For Injection And Infusion Solution
10 1Powder For Concentrate For Injection Or Infusion Solution
11 2Powder to concentrate to the Injection/infusion fluid, resolution
12 1SOLUTION
13 3SOLUTION;INTRAVENOUS
14 1Blank
01 1Approved
02 1Authorized
03 2Cancelled
04 5DISCN
05 3Deregistered
06 2Generic
07 5Prescription
08 10RX
09 8Blank
01 2ANGIOMAX
02 1ANGIOMAX RTU
03 4Angiox
04 13BIVALIRUDIN
05 1BIVALIRUDIN ARX
06 3BIVALIRUDIN FOR INJECTION
07 2BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
08 1BIVALIRUDIN INJECTION
09 1Bivalirudin Accord
10 1Bivalirudin Cipla
11 1Bivalirudin Reig Jofre
12 1Bivalirudina Accord
13 1Bivalirudina Cipla
14 1Bivalirudina Sala
15 4Blank
01 1Australia
02 5Canada
03 1China
04 3India
05 1Italy
06 2Norway
07 3Spain
08 4Sweden
09 17USA
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Regulatory Info : RX
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 2017-05-26
Application Number : 201577
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 2017-11-22
Application Number : 206551
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 2017-07-06
Application Number : 204876
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 2018-07-27
Application Number : 205962
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 250MG/50ML (5MG/ML)
Packaging :
Approval Date : 2017-12-21
Application Number : 208374
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 500MG/100ML (5MG/ML)
Packaging :
Approval Date : 2017-12-21
Application Number : 208374
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : Injection
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 2016-10-28
Application Number : 90189
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 2019-10-23
Application Number : 210031
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 2015-07-14
Application Number : 90811
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 2015-07-14
Application Number : 90816
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : Generic
Registration Country : India
Brand Name :
Dosage Form : Lyo.Inj
Dosage Strength : 250MG
Packaging :
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : India
Regulatory Info : RX
Registration Country : USA
Brand Name : ANGIOMAX RTU
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : 250MG/50ML (5MG/ML)
Packaging :
Approval Date : 2019-07-25
Application Number : 211215
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 2018-07-16
Application Number : 91602
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date :
Application Number : 91206
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ANGIOMAX
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 2000-12-15
Application Number : 20873
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 2021-05-28
Application Number : 213078
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date :
Application Number : 91468
Regulatory Info :
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : BIVALIRUDIN
Dosage Form : INJECTABLE;INTRAVENOUS
Dosage Strength : 250MG/VIAL
Packaging :
Approval Date : 2018-06-01
Application Number : 202471
Regulatory Info : RX
Registration Country : USA
Regulatory Info :
Registration Country : Italy
Brand Name : Angiox
Dosage Form : Bivalirudin 250Mg 10 Units Parenteral Use
Dosage Strength : 10 VIALS EV 250 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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