Topotecan Injectable Solution
- Brand(s)
- Hycamtin
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Hospira, Inc. (2014-07-15)
- Oldest Current Product
- 2010-11-28
- License(s)
- NDA, ANDA
- RxNORM
- INJECTABLE SOLUTION\TOPOTECAN
- FDAOB
- INJECTION\INJECTION\TOPOTECAN HYDROCHLORIDE\rdfq
INTRAVENOUS\SOLUTION\TOPOTECAN HYDROCHLORIDE - SPL Active
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\TOPOTECAN HYDROCHLORIDE
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TOPOTECAN HYDROCHLORIDE
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\TOPOTECAN HYDROCHLORIDE
INTRAVENOUS\INJECTION\TOPOTECAN HYDROCHLORIDE - SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, FOR SOLUTION\TOPOTECAN
INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\TOPOTECAN
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\TOPOTECAN
INTRAVENOUS\INJECTION\TOPOTECAN
product(s) by strength(s)
topotecan 1 mg/ml injectable solution
original product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 004090302 | NDA | Hospira, Inc. | 2011-02-02, 2013-09-24 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | NDA200582 | 1d4e1cce-c57e-4a8b-be96-f95a2778e221, cc201919-b959-46ce-b0a8-2020e08d500a |
| 2 | 250210236 | NDA | Sagent Pharmaceuticals | 2014-12-15 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, SOLUTION, CONCENTRATE | NDA022453 | e5e6600e-6f92-4dc9-a8f3-cf647471d3cb |
generic product(s)(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 000690075 | ANDA | Pfizer Labs | 2012-08-29 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA091542 | 22a58c47-f126-4701-a120-b3701d07a916 |
| 2 | 167290151 | ANDA | Accord Healthcare Inc. | 2013-07-23 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA202351 | 729b2b22-1344-44f3-b614-14f6ec3c263e |
| 3 | 250210206 | ANDA | Sagent Pharmaceuticals | 2010-11-28 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA091284 | 6317ed83-75e3-4392-874b-9818c15a067d |
| 4 | 250210824 | ANDA | Sagent Pharmaceuticals | 2011-06-27 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA090620 | b75e8568-e5f0-41f5-948b-fc9f807533b5 |
| 5 | 459630615 | ANDA | Actavis Inc. | 2015-01-05 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA090620 | 996430c0-ee26-4ed9-82b8-a8b645becba6 |
| 6 | 553900370 | ANDA | Bedford Laboratories | 2011-04-18 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA201191 | a439bf07-53db-0352-846a-99d9da772f9b |
| 7 | 627560023 | ANDA | Sun Pharmaceutical Industries Limited | 2015-09-02 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA202203 | f394ace4-e201-4055-acea-453830d103a6 |
| 8 | 633230762 | ANDA | App Pharmaceuticals, Llc | 2010-11-29, 2010-11-30 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA091089, ANDA091376 | 79f3b5ee-fc95-47c3-96a4-55dd91121e55, b094e6ba-7cf6-4fb8-8683-73d324650dd3 |
| 9 | 664350410 | ANDA | Kadmon Pharmaceuticals, Llc | 2010-12-02 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, POWDER, FOR SOLUTION | ANDA091199 | 715620fb-614f-40b6-8d3d-8494843d8518 |
| 10 | 674570474 | ANDA | Mylan Institutional Llc | 2012-08-29 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | ANDA091542 | 1ca916c3-48dc-498d-8b5c-dab735c29e42 |
invalid application product(s)
| # | id | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 667580051 | NDA | Sandoz Inc | 2011-02-25 | TOPOTECAN HYDROCHLORIDE | INTRAVENOUS | INJECTION | NDA200199 | 6bc88223-4de9-4ff7-b59f-e479c1fce600 |
application(s)
| # | id | title | deprecated | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|---|
| 1 | ANDA090620 | TOPOTECAN HYDROCHLORIDE | ACTAVIS TOTOWA LLC | 2010-12-02 | ANDA090620_001 | ||
| 2 | ANDA091089 | TOPOTECAN HYDROCHLORIDE | FRESENIUS KABI USA LLC | 2010-11-29 | ANDA091089_001 | ||
| 3 | ANDA091199 | TOPOTECAN HYDROCHLORIDE | CIPLA LTD | 2010-12-01 | ANDA091199_001 | ||
| 4 | ANDA091284 | TOPOTECAN HYDROCHLORIDE | SAGENT PHARMACEUTICALS INC | 2011-01-26 | ANDA091284_001 | ||
| 5 | ANDA091376 | TOPOTECAN HYDROCHLORIDE | True | FRESENIUS KABI ONCOLOGY PLC | 2010-11-29 | ANDA091376_001 | |
| 6 | ANDA091542 | TOPOTECAN HYDROCHLORIDE | MYLAN LABORATORIES LTD | 2012-08-28 | ANDA091542_001 | ||
| 7 | ANDA201166 | TOPOTECAN HYDROCHLORIDE | CHEM WERTH INC | 2012-08-08 | ANDA201166_001 | ||
| 8 | ANDA201191 | TOPOTECAN HYDROCHLORIDE | DR REDDYS LABORATORIES LTD | 2011-03-09 | ANDA201191_001 | ||
| 9 | ANDA202203 | TOPOTECAN HYDROCHLORIDE | SUN PHARMACEUTICAL INDUSTRIES LTD | 2013-08-29 | ANDA202203_001 | ||
| 10 | ANDA202351 | TOPOTECAN HYDROCHLORIDE | ACCORD HEALTHCARE INC | 2013-06-26 | ANDA202351_001 | ||
| 11 | NDA020671 | HYCAMTIN | NOVARTIS PHARMACEUTICALS CORP | 1996-05-28 | p5674872, TREATMENT OF METASTATIC CARCINOMA OF THE OVARY AFTER FAILURE OF INITIAL OR SUBSEQUENT CHEMOTHERAPY | NDA020671_001 | |
| 12 | NDA022453 | TOPOTECAN HYDROCHLORIDE | TEVA PHARMACEUTICALS USA | 2012-12-20 | NDA022453_001 | ||
| 13 | NDA200199 | TOPOTECAN | True | SANDOZ INC | 2011-02-25 | NDA200199_001, NDA200199_002, NDA200199_003 | |
| 14 | NDA200582 | TOPOTECAN HYDROCHLORIDE | HOSPIRA INC | 2011-02-02 | NDA200582_001 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | TE | approved | application |
|---|---|---|---|---|---|---|---|---|---|
| 1 | ANDA090620_001 | RX | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL) | INJECTION | False | AP | 2010-12-02 | TOPOTECAN HYDROCHLORIDE | |
| 2 | ANDA091089_001 | RX | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL) | INJECTION | False | AP | 2010-11-29 | TOPOTECAN HYDROCHLORIDE | |
| 3 | ANDA091199_001 | RX | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL) | INJECTION | False | AP | 2010-12-01 | TOPOTECAN HYDROCHLORIDE | |
| 4 | ANDA091284_001 | RX | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL) | INJECTION | False | AP | 2011-01-26 | TOPOTECAN HYDROCHLORIDE | |
| 5 | ANDA091376_001 | discontinued | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL) | INJECTION | False | 2010-11-29 | TOPOTECAN HYDROCHLORIDE | ||
| 6 | ANDA091542_001 | RX | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL) | INJECTION | False | AP | 2012-08-28 | TOPOTECAN HYDROCHLORIDE | |
| 7 | ANDA201166_001 | RX | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL) | INJECTION | False | AP | 2012-08-08 | TOPOTECAN HYDROCHLORIDE | |
| 8 | ANDA201191_001 | RX | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL) | INJECTION | False | AP | 2011-03-09 | TOPOTECAN HYDROCHLORIDE | |
| 9 | ANDA202203_001 | RX | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL) | INJECTION | False | AP | 2013-08-29 | TOPOTECAN HYDROCHLORIDE | |
| 10 | ANDA202351_001 | RX | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL) | INJECTION | False | AP | 2013-06-26 | TOPOTECAN HYDROCHLORIDE | |
| 11 | NDA020671_001 | RX | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/VIAL) | INJECTION | True | AP | 1996-05-28 | HYCAMTIN | |
| 12 | NDA022453_001 | RX | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/4ML) | INTRAVENOUS | SOLUTION | False | AP | 2012-12-20 | TOPOTECAN HYDROCHLORIDE |
| 13 | NDA200199_001 | discontinued | TOPOTECAN HYDROCHLORIDE (EQ 1MG BASE/ML) | INTRAVENOUS | SOLUTION | False | 2011-02-25 | TOPOTECAN | |
| 14 | NDA200199_002 | discontinued | TOPOTECAN HYDROCHLORIDE (EQ 3MG BASE/3ML) | INTRAVENOUS | SOLUTION | False | 2011-02-25 | TOPOTECAN | |
| 15 | NDA200199_003 | discontinued | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/4ML) | INTRAVENOUS | SOLUTION | False | 2011-02-25 | TOPOTECAN | |
| 16 | NDA200582_001 | RX | TOPOTECAN HYDROCHLORIDE (EQ 4MG BASE/4ML) | INTRAVENOUS | SOLUTION | True | AP | 2011-02-02 | TOPOTECAN HYDROCHLORIDE |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p5674872 (view patent) | 2014-10-07 | NDA020671 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 1ca916c3-48dc-498d-8b5c-dab735c29e42 (view SPL) | These highlights do not include all the information needed to use Topotecan Hydrochloride for Injection safely and effectively. See full prescribing information for Topotecan Hydrochloride for Injection.TOPOTECAN hydrochloride for injection, for intravenous use.Initial U.S. Approval: 1996 | prescription | Human Prescription | Mylan Institutional Llc | Analysis, Label, Manufacture, Pack, Sterilize | 2014-07-01 | 1 | 674570474 |
| 2 | 1d4e1cce-c57e-4a8b-be96-f95a2778e221 (view SPL) | These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection. TOPOTECAN INJECTION Must be diluted before intravenous infusion Initial U.S. Approval: 1996 | prescription | Human Prescription | Hospira, Inc. | 2014-07-15 | 16 | 004090302 | |
| 3 | 22a58c47-f126-4701-a120-b3701d07a916 (view SPL) | These highlights do not include all the information needed to use Topotecan Hydrochloride for Injection safely and effectively. See full prescribing information for Topotecan Hydrochloride for Injection.Initial U.S. Approval: 1996 | prescription | Human Prescription | Pfizer Labs | Analysis, Manufacture, Pack, Sterilize | 2012-09-10 | 1 | 000690075 |
| 4 | 3c15da96-d309-4b93-f5aa-cfb52c25c174 (view SPL) | These highlights do not include all the information needed to use HYCAMTIN safely and effectively. See full prescribing information for HYCAMTIN.HYCAMTIN (topotecan) for injectionInitial U.S. Approval: 1996 | prescription | Human Prescription | Glaxosmithkline Llc | 2015-06-02 | 10 | 000074201 | |
| 5 | 6317ed83-75e3-4392-874b-9818c15a067d (view SPL) | These highlights do not include all the information needed to use topotecan hydrochloride safely and effectively. See full prescribing information for topotecan hydrochloride. Topotecan Hydrochloride for Injection Initial U.S. Approval: 1996 | prescription | Human Prescription | Sagent Pharmaceuticals | 2010-11-26 | 4 | 250210206 | |
| 6 | 6bc88223-4de9-4ff7-b59f-e479c1fce600 (view SPL) | These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection. Must be diluted before intravenous infusion Initial U.S. Approval: 1996 | prescription | Human Prescription | Sandoz Inc | 2011-03-09 | 1 | 667580051 | |
| 7 | 715620fb-614f-40b6-8d3d-8494843d8518 (view SPL) | These highlights do not include all the information needed to use (Topotecan Hydrochloride for Injection) safely and effectively. See full prescribing information for (Topotecan Hydrochloride for Injection). Topotecan Hydrochloride for InjectionInitial U.S. Approval: 1996 | prescription | Human Prescription | Kadmon Pharmaceuticals, Llc | API MANUFACTURE, MANUFACTURE | 2010-12-10 | 1 | 664350410 |
| 8 | 729b2b22-1344-44f3-b614-14f6ec3c263e (view SPL) | These highlights do not include all the information needed to use topotecan for injection safely and effectively. See full prescribing information for topotecan for injection. TOPOTECAN for injection Initial U.S. Approval: 1996 | prescription | Human Prescription | Accord Healthcare Inc. | analysis, manufacture | 2015-10-23 | 5 | 167290151 |
| 9 | 79f3b5ee-fc95-47c3-96a4-55dd91121e55 (view SPL) | These highlights do not include all the information needed to use Topotecan Hydrochloride for Injection safely and effectively. See full prescribing information for Topotecan Hydrochloride for Injection.Topotecan Hydrochloride for InjectionInitial U.S. Approval: 1996 | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2010-11-25 | 5 | 633230762 |
| 10 | 9683e3be-7d23-4ba7-9fe9-9762963604f0 (view SPL) | These highlights do not include all the information needed to use TOPOTECAN INJECTION safely and effectively. See full prescribing information for TOPOTECAN INJECTION. TOPOTECAN INJECTION, for intravenous use Initial U.S. Approval: 1996 | prescription | Human Prescription | Teva Parenteral Medicines, Inc | 2014-03-07 | 4 | 007034714 | |
| 11 | 996430c0-ee26-4ed9-82b8-a8b645becba6 (view SPL) | These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION. TOPOTECAN hydrochloride for injection, for intravenous use Initial U.S. Approval: 1996 | prescription | Human Prescription | Actavis Inc. | ANALYSIS, LABEL, MANUFACTURE, PACK | 2015-07-31 | 5 | 459630615 |
| 12 | a439bf07-53db-0352-846a-99d9da772f9b (view SPL) | These highlights do not include all the information needed to use (Topotecan Hydrochloride For Injection) safely and effectively. See full prescribing information for (topotecan hydrochloride for injection). Topotecan Hydrochloride For Injection Initial U.S. Approval: 1996 | prescription | Human Prescription | Bedford Laboratories | analysis, manufacture | 2014-04-11 | 3 | 553900370 |
| 13 | b094e6ba-7cf6-4fb8-8683-73d324650dd3 (view SPL) | These highlights do not include all the information needed to use Topotecan Hydrochloride for Injection safely and effectively. See full prescribing information for Topotecan Hydrochloride for Injection. Topotecan Hydrochloride for Injection Initial U.S. Approval: 1996 | prescription | Human Prescription | App Pharmaceuticals, Llc | MANUFACTURE | 2013-03-01 | 1 | 633230762 |
| 14 | b75e8568-e5f0-41f5-948b-fc9f807533b5 (view SPL) | These highlights do not include all the information needed to use Topotecan Hydrochloride for Injection safely and effectively. See full prescribing information for Topotecan Hydrochloride for Injection. Topotecan Hydrochloride for Injection Initial U.S. Approval: 1996 | prescription | Human Prescription | Sagent Pharmaceuticals | 2011-03-10 | 1 | 250210824 | |
| 15 | cc201919-b959-46ce-b0a8-2020e08d500a (view SPL) | These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection. TOPOTECAN INJECTION Must be diluted before intravenous infusion Initial U.S. Approval: 1996 | prescription | Human Prescription | Hospira, Inc. | 2014-07-15 | 1 | 004090302 | |
| 16 | e5e6600e-6f92-4dc9-a8f3-cf647471d3cb (view SPL) | These highlights do not include all the information needed to use Topotecan Injection safely and effectively. See full prescribing information for Topotecan Injection.Topotecan Injection, for intravenous useInitial U.S. Approval: 1996 | prescription | Human Prescription | Sagent Pharmaceuticals | 2014-09-12 | 3 | 250210236 | |
| 17 | f394ace4-e201-4055-acea-453830d103a6 (view SPL) | These highlights do not include all the information needed to use TOPOTECAN HYDROCHLORIDE FOR INJECTION safely and effectively. See full prescribing information for TOPOTECAN HYDROCHLORIDE FOR INJECTION TOPOTECAN hydrochloride for injection For Intravenous Infusion Initial U.S. Approval: 1996 | prescription | Human Prescription | Sun Pharmaceutical Industries Limited | ANALYSIS, MANUFACTURE | 2015-09-02 | 5 | 627560023 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII