Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070311
Company: HIKMA

Products on ANDA 70311

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DIAZEPAM	DIAZEPAM	50MG/10ML (5MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No
DIAZEPAM	DIAZEPAM	5MG/ML (5MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No
DIAZEPAM	DIAZEPAM	10MG/2ML (5MG/ML)	INJECTABLE;INJECTION	Discontinued	None	No	No

Labels for ANDA 070311

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/12/2021	SUPPL-22	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/070311s022lbl.pdf