Orange Book product · Brand (NDA)
PRIMAXIN
CILASTATIN SODIUM; IMIPENEM
At a glance
Nov 26, 1985
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 26, 1985
41 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
CILASTATIN SODIUM; IMIPENEM
Strength
EQ 500MG BASE/VIAL;500MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AP
Application
NDA 050587
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.
- 1990PRIMAXINBrand (NDA)
NDA 050630 · MERCK
- 2019IMIPENEM AND CILASTATINGeneric (ANDA)
ANDA 207594 · HQ SPCLT PHARMA
- 2011IMIPENEM AND CILASTATINGeneric (ANDA)
ANDA 090577 · ACS DOBFAR
- 2011IMIPENEM AND CILASTATINGeneric (ANDA)
ANDA 090825 · HOSPIRA INC
- 2011IMIPENEM AND CILASTATINGeneric (ANDA)
ANDA 091007 · HOSPIRA INC
- 1987PRIMAXINGeneric (ANDA)
ANDA 062756 · MERCK
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.
