Orange Book product · Generic (ANDA)
TOPOTECAN HYDROCHLORIDE
TOPOTECAN HYDROCHLORIDE
At a glance
Nov 29, 2010
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 29, 2010
15 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
TOPOTECAN HYDROCHLORIDE
Strength
EQ 4MG BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
ANDA 091376
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TOPOTECAN HYDROCHLORIDE
- 2012TOPOTECAN HYDROCHLORIDEBrand (NDA)
NDA 022453 · MEITHEAL
- 2011TOPOTECANBrand (NDA)
NDA 200199 · SANDOZ INC
- 2011TOPOTECAN HYDROCHLORIDEBrand (NDA)
NDA 200582 · HOSPIRA INC
- 2007HYCAMTINBrand (NDA)
NDA 020981 · SANDOZ
- 1996HYCAMTINBrand (NDA)
NDA 020671 · SANDOZ
- 2017TOPOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 206074 · NATCO PHARMA USA
- 2017TOPOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 204406 · ACCORD HLTHCARE
- 2016TOPOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 206962 · INGENUS PHARMS LLC
- 2013TOPOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 202203 · SUN PHARM INDS LTD
- 2013TOPOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 202351 · ACCORD HLTHCARE
- 2012TOPOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 091542 · RISING
- 2012TOPOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 201166 · MEITHEAL
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
