Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075243
Company: HIKMA
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/20/2000 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75243ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75243ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/10/2021 SUPPL-36 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/27/2017 SUPPL-26 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/08/2009 SUPPL-18 Labeling

Label is not available on this site.

03/03/2009 SUPPL-12 Labeling

Label is not available on this site.

12/04/2003 SUPPL-4 Labeling

Label is not available on this site.

11/30/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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 075494 AKORN
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 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

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 AKORN
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 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

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