Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090696
Company: GLAND PHARMA LTD
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/29/2012 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
04/27/2017 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

04/27/2017 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

08/28/2012 SUPPL-2 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

06/20/2012 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

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 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 075856 HOSPIRA
MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075243 WEST-WARD PHARMS INT
MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075247 WEST-WARD PHARMS INT
MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075324 WEST-WARD PHARMS INT
MIDAZOLAM HYDROCHLORIDE MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML INJECTABLE;INJECTION Prescription No AP 075421 WEST-WARD PHARMS INT
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

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