Orange Book product · Brand (NDA)
GEMCITABINE HYDROCHLORIDE
GEMCITABINE HYDROCHLORIDE
At a glance
Aug 04, 2011
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 04, 2011
15 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
GEMCITABINE HYDROCHLORIDE
Strength
1GM/26.3ML (38MG/ML)
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 200795
Product number
002
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.
- 2025INLEXZOBrand (NDA)
NDA 219683 · JANSSEN BIOTECH
- 2025AVGEMSIBrand (NDA)
NDA 219920 · AVYXA HOLDINGS
- 2018INFUGEMBrand (NDA)
NDA 208313 · SUN PHARM
- 2017GEMCITABINE HYDROCHLORIDEBrand (NDA)
NDA 209604 · ACCORD HLTHCARE
- 1996GEMZARBrand (NDA)
NDA 020509 · LILLY
- 2023GEMCITABINE HYDROCHLORIDEGeneric (ANDA)
ANDA 213175 · HIKMA
- 2021GEMCITABINE HYDROCHLORIDEGeneric (ANDA)
ANDA 206617 · HIKMA INTL PHARMS
- 2020GEMCITABINE HYDROCHLORIDEGeneric (ANDA)
ANDA 212129 · MEITHEAL
- 2019GEMCITABINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210991 · SHILPA
- 2019GEMCITABINE HYDROCHLORIDEGeneric (ANDA)
ANDA 207575 · SHILPA
- 2019GEMCITABINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210383 · INGENUS PHARMS LLC
- 2018GEMCITABINE HYDROCHLORIDEGeneric (ANDA)
ANDA 209077 · SAGENT PHARMS INC
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.
