FDA Drug NDCs and Drug Labels for meropenem

Manufacturer Route Drug Strength NDCs Type Application Holder Approval Date PI / Labels / Letters
Savior Lifetec intravenous meropenem 500 mg/20mL 44647-032-10 ANDA SAVIOR LIFETEC CORP 2016-04-19
AuroMedics Phar intravenous meropenem 1 g/1 55150-208-30 ANDA AUROBINDO PHARMA LTD 2017-03-27
Civica, Inc intravenous meropenem 500 mg/20mL 72572-415-10 ANDA SAVIOR LIFETEC CORP 2020-09-23
Fresenius Kabi ━ Premier ProRx intravenous meropenem 1 g/20mL 63323-508-25 ANDA ACS DOBFAR 2011-10-26
Filing Details
NDA Filings
Melinta T , B. Braun , Pfizer La
ANDAs (Approved New Drug Applications)
Savior Li , AuroMedic , Civica, I , Fresenius , BluePoint , WG Critic , Sandoz In , Amneal Ph , Hospira, , Daewoong , Xellia Ph , Gland Pha , ACS DOBFA
Private Labels

Premier
Fresenius Kabi USA, LLC - MEROPENEM - INTRAVENOUS - 63323-508-25 - 1 g/20mL

Civica
SAVIOR LIFETEC CORP - MEROPENEM - INTRAVENOUS - 72572-415-10 - 500 mg/20mL

Civica
SAVIOR LIFETEC CORP - MEROPENEM - INTRAVENOUS - 72572-416-10 - 1 g/30mL

BluePoint
AMNEAL PHARMS - MEROPENEM - INTRAVENOUS - 68001-323-31 - 500 mg/20mL