Orange Book product · Brand (NDA)
PRIMAXIN
CILASTATIN SODIUM; IMIPENEM
At a glance
Dec 14, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 14, 1990
36 yr ago
Today
Pharmaceutical detail
Active ingredient
CILASTATIN SODIUM; IMIPENEM
Strength
EQ 500MG BASE/VIAL;500MG/VIAL
Dosage form
POWDER
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 050630
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 1985PRIMAXINBrand (NDA)
NDA 050587 · 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.
