FDA Orange Book · active-ingredient family
Cilastatin sodium; imipenem
Cilastatin sodium; imipenem is approved as 2 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PRIMAXIN · NDA 050587
2
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRIMAXINRLD×2 | MERCK | NDA 050587 | — | Nov 26, 1985 | |
| PRIMAXIN×2 | MERCK | NDA 050630 | — | Dec 14, 1990 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IMIPENEM AND CILASTATIN | HQ SPCLT PHARMA | ANDA 207594 | AP | Dec 12, 2019 | |
| IMIPENEM AND CILASTATIN×2 | ACS DOBFAR | ANDA 090577 | — | Dec 21, 2011 | |
| IMIPENEM AND CILASTATIN×2 | HOSPIRA INC | ANDA 090825 | — | Nov 16, 2011 | |
| IMIPENEM AND CILASTATIN | HOSPIRA INC | ANDA 091007 | — | Nov 16, 2011 | |
| PRIMAXIN×2 | MERCK | ANDA 062756 | — | Jan 08, 1987 |
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.
Cilastatin sodium; imipenem — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
