An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 217504
Company: MICRO LABS

Products on ANDA 217504

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217504

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/21/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 217504

MIDAZOLAM HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 1MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075154	FRESENIUS KABI USA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	090696	GLAND PHARMA LTD
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075243	HIKMA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075247	HIKMA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075324	HIKMA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075421	HIKMA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	212847	HIKMA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075293	HOSPIRA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	217504	MICRO LABS
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075494	RISING
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	203460	FRESENIUS KABI USA
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075857	HOSPIRA
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	090315	ONESOURCE SPECIALTY
MIDOZALAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	090316	ONESOURCE SPECIALTY

INJECTABLE;INJECTION; EQ 5MG BASE/ML
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075154	FRESENIUS KABI USA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	090850	GLAND PHARMA LTD
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075243	HIKMA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075247	HIKMA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075324	HIKMA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075421	HIKMA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	212847	HIKMA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075293	HOSPIRA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	217504	MICRO LABS
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075494	RISING
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	203460	FRESENIUS KABI USA
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	075857	HOSPIRA
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	090315	ONESOURCE SPECIALTY
MIDOZALAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	090316	ONESOURCE SPECIALTY

Top