Orange Book product · Brand (NDA)
INVANZ
ERTAPENEM SODIUM
At a glance
Nov 21, 2001
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 21, 2001
24 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
ERTAPENEM SODIUM
Strength
EQ 1GM BASE/VIAL
Dosage form
INJECTABLE
Route
INTRAMUSCULAR, INTRAVENOUS
TE code
AP
Application
NDA 021337
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.
- 2024ERTAPENEM SODIUMGeneric (ANDA)
ANDA 218067 · QILU ANTIBIOTICS
- 2023ERTAPENEM SODIUMGeneric (ANDA)
ANDA 209145 · SUN PHARM
- 2021ERTAPENEM SODIUMGeneric (ANDA)
ANDA 212040 · GLAND
- 2019ERTAPENEM SODIUMGeneric (ANDA)
ANDA 207647 · SAVIOR LIFETEC CORP
- 2018ERTAPENEM SODIUMGeneric (ANDA)
ANDA 209133 · EUGIA PHARMA
- 2018ERTAPENEM SODIUMGeneric (ANDA)
ANDA 208790 · ACS DOBFAR SPA
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.
