Orange Book product · Generic (ANDA)
IMIPENEM AND CILASTATIN
CILASTATIN SODIUM; IMIPENEM
At a glance
Nov 16, 2011
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 16, 2011
14 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
CILASTATIN SODIUM; IMIPENEM
Strength
EQ 500MG BASE/VIAL;500MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
ANDA 091007
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of CILASTATIN SODIUM; IMIPENEM
- 1990PRIMAXINBrand (NDA)
NDA 050630 · MERCK
- 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
- 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.
