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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203460
Company: FRESENIUS KABI USA

Products on ANDA 203460

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203460

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/22/2014	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2023	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
05/26/2020	SUPPL-9	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.
06/05/2017	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
06/05/2017	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
12/27/2016	SUPPL-4	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 203460

MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE

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

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