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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075247
Company: HIKMA

Products on ANDA 075247

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075247

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2000	ORIG-1	Approval			Letter (PDF) Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75247ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75247ta.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2023	SUPPL-14	Labeling-Package Insert		Label is not available on this site.
07/09/2003	SUPPL-3	Labeling		Label is not available on this site.
04/03/2001	SUPPL-1	Manufacturing (CMC)-Microbiology-Processing		Label is not available on this site.

Therapeutic Equivalents for ANDA 075247

MIDAZOLAM HYDROCHLORIDE

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	075494	EPIC PHARMA LLC
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 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	STERISCIENCE
MIDOZALAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	090316	STERISCIENCE

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	075494	EPIC PHARMA LLC
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 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	STERISCIENCE
MIDOZALAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML	INJECTABLE;INJECTION	Prescription	No	AP	090316	STERISCIENCE

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