Orange Book product · Brand (NDA)
MEROPENEM
MEROPENEM
At a glance
Jul 26, 2023
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 26, 2023
2 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
MEROPENEM
Strength
2GM/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
AP
Application
NDA 215212
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.
- 2015MEROPENEM AND SODIUM CHLORIDE IN DUPLEX CONTAINERBrand (NDA)
NDA 202106 · B BRAUN MEDICAL
- 1996MERREM IVBrand (NDA)
NDA 050706 · PFIZER
- 2025MEROPENEMGeneric (ANDA)
ANDA 219084 · BROOKS STERISCIENCE
- 2024MEROPENEMGeneric (ANDA)
ANDA 216424 · QILU
- 2022MEROPENEMGeneric (ANDA)
ANDA 216154 · BROOKS STERISCIENCE
- 2019MEROPENEMGeneric (ANDA)
ANDA 210773 · HQ SPCLT PHARMA
- 2017MEROPENEMGeneric (ANDA)
ANDA 205835 · EUGIA PHARMA
- 2016MEROPENEMGeneric (ANDA)
ANDA 204139 · ACS DOBFAR SPA
- 2016MEROPENEMGeneric (ANDA)
ANDA 206141 · GLAND
- 2016MEROPENEMGeneric (ANDA)
ANDA 206086 · SAVIOR LIFETEC CORP
- 2016MEROPENEMGeneric (ANDA)
ANDA 205883 · AMNEAL PHARMS
- 2015MEROPENEMGeneric (ANDA)
ANDA 204854 · DAEWOONG PHARM CO
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.
