Orange Book product · Brand (NDA)
HYCAMTIN
TOPOTECAN HYDROCHLORIDE
At a glance
May 28, 1996
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 28, 1996
30 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
TOPOTECAN HYDROCHLORIDE
Strength
EQ 4MG BASE/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 020671
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2012TOPOTECAN HYDROCHLORIDEBrand (NDA)
NDA 022453 · MEITHEAL
- 2011TOPOTECANBrand (NDA)
NDA 200199 · SANDOZ INC
- 2011TOPOTECAN HYDROCHLORIDEBrand (NDA)
NDA 200582 · HOSPIRA INC
- 2007HYCAMTINBrand (NDA)
NDA 020981 · 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
- 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.
