Orange Book product · Generic (ANDA)
TOPOTECAN HYDROCHLORIDE
TOPOTECAN HYDROCHLORIDE
At a glance
Nov 24, 2017
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 24, 2017
8 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
TOPOTECAN HYDROCHLORIDE
Strength
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 206074
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 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
- 2011TOPOTECAN HYDROCHLORIDEGeneric (ANDA)
ANDA 201191 · DR REDDYS LABS LTD
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.
