Drug application

IMIPENEM AND CILASTATIN (CILASTATIN SODIUM, IMIPENEM)

Drugs@FDA ANDA 207594 · HQ SPCLT PHARMA

Key facts

Drug name IMIPENEM AND CILASTATIN
Active ingredients CILASTATIN SODIUM, IMIPENEM
Application type ANDA
Application number 207594
Company HQ SPCLT PHARMA
Dosage forms POWDER, INTRAVENOUS
Strength EQ 500MG BASE/VIAL;500MG/VIAL
Marketing status Prescription
TE codes AP
Reference listed drug No
Latest submission status date Dec 12, 2019

At a glance

  • 1–9 Submissions
  • 1–9 Supplements
  • None Label versions
  • 1–9 Products
  • 1–9 Therapeutic equivalents

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About Drugs@FDA applications

Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.

Source: U.S. Food and Drug Administration (FDA), Drugs@FDA

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