01 2Accord Healthcare Pty. Ltd.
02 7Accord healthcare
03 1Accure Labs
04 4Actavis Inc
05 1Dash Pharmaceuticals
06 1Fresenius Kabi AB Brunna
07 1Fresenius Kabi Oncology Limited
08 2Fresenius Kabi USA
09 2Grupo Azevedos
10 3Hospira, Inc.
11 1Medivision
12 2Meitheal Pharmaceuticals
13 1Novast Laboratories
14 1Pfizer Inc
15 1Pharmascience Inc.
16 1Rising Pharmaceuticals Inc
17 1Sagent Pharmaceuticals
18 1Sakar Healthcare
19 12Sandoz B2B
20 1Sun Pharmaceutical Industries Limited
21 2Teva Pharmaceutical Industries
22 1Teyro Labs
23 1Viatris
24 2Vinkem Labs Ltd
25 1XYZ Pharma
01 2CAP
02 2CAPSULE;ORAL
03 2Concentrate for solution for infusion
04 3Concentrate to the infusion fluid, resolution
05 2INJ
06 12INJECTABLE;INJECTION
07 1INJECTION
08 3Injection
09 2POWDER FOR SOLUTION
10 2Powder to concentrate to the infusion fluid, resolution
11 3SOLUTION
12 8SOLUTION;INTRAVENOUS
13 3Topotecan 4Mg 1 Unit Parenteral Use
14 1Topotecan 4Mg 4Ml 1 Units Parenteral Use
15 3Topotecan 4Mg 4Ml 5 Units Parenteral Use
16 4Blank
01 9DISCN
02 2Generic
03 3Originator
04 1Prescription
05 13RX
06 25Blank
01 3HYCAMTIN
02 2Hycamtin
03 1Hycamtin 0.25mg
04 1Hycamtin 1mg
05 1Hycamtin 5Ml
06 1Meditop 4 mg
07 1PMS-TOPOTECAN
08 2Potactasol
09 1TEVA-TOPOTECAN
10 3TOPOTECAN
11 16TOPOTECAN HYDROCHLORIDE
12 2TOPOTECAN HYDROCHLORIDE FOR INJECTION
13 1TOPOTECAN INJECTION
14 6Topotecan
15 4Topotecan Accord
16 1Topotecan Hospira
17 1Topotecan The Fresenius Kabi
18 6Blank
01 4Australia
02 5Canada
03 4India
04 7Italy
05 5Norway
06 2Portugal
07 4South Africa
08 22USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG BASE/VIAL
Packaging :
Approval Date : 2013-06-26
Application Number : 202351
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 1MG BASE/ML (EQ 1MG BASE/ML)
Packaging :
Approval Date : 2017-07-06
Application Number : 204406
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Packaging :
Approval Date : 2017-07-06
Application Number : 204406
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG BASE/VIAL
Packaging :
Approval Date : 2010-12-02
Application Number : 90620
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG BASE/VIAL
Packaging :
Approval Date : 2010-11-29
Application Number : 91089
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG BASE/VIAL
Packaging :
Approval Date : 2010-11-29
Application Number : 91376
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Packaging :
Approval Date : 2011-02-02
Application Number : 200582
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Packaging :
Approval Date : 2012-12-20
Application Number : 22453
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG BASE/VIAL
Packaging :
Approval Date : 2012-08-08
Application Number : 201166
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG BASE/VIAL
Packaging :
Approval Date : 2012-08-28
Application Number : 91542
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG BASE/VIAL
Packaging :
Approval Date : 2011-01-26
Application Number : 91284
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : HYCAMTIN
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG BASE/VIAL
Packaging :
Approval Date : 1996-05-28
Application Number : 20671
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : HYCAMTIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 0.25MG BASE
Packaging :
Approval Date : 2007-10-11
Application Number : 20981
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : HYCAMTIN
Dosage Form : CAPSULE;ORAL
Dosage Strength : EQ 1MG BASE
Packaging :
Approval Date : 2007-10-11
Application Number : 20981
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TOPOTECAN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2011-02-25
Application Number : 200199
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TOPOTECAN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 3MG BASE/3ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2011-02-25
Application Number : 200199
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TOPOTECAN
Dosage Form : SOLUTION;INTRAVENOUS
Dosage Strength : EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Packaging :
Approval Date : 2011-02-25
Application Number : 200199
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG BASE/VIAL
Packaging :
Approval Date : 2013-08-29
Application Number : 202203
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG BASE/VIAL
Packaging :
Approval Date : 2010-12-01
Application Number : 91199
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : TOPOTECAN HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 4MG BASE/VIAL
Packaging :
Approval Date : 2011-03-09
Application Number : 201191
Regulatory Info : RX
Registration Country : USA
