Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075873
Company: HIKMA

Products on ANDA 075873

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP;ORAL	Prescription	AA	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075873

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75873.TA.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/17/2023	SUPPL-13	Labeling-Package Insert		Label is not available on this site.
04/27/2017	SUPPL-11	Labeling-Package Insert		Label is not available on this site.
04/27/2017	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/12/2007	SUPPL-6	Labeling		Label is not available on this site.
05/20/2004	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 075873

MIDAZOLAM HYDROCHLORIDE

SYRUP;ORAL; EQ 2MG BASE/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP;ORAL	Prescription	No	AA	075873	HIKMA
MIDAZOLAM HYDROCHLORIDE	MIDAZOLAM HYDROCHLORIDE	EQ 2MG BASE/ML	SYRUP;ORAL	Prescription	No	AA	076379	PADAGIS US