Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076150
Company: INTL MEDICATION SYS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORAZEPAM LORAZEPAM 2MG/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
11/15/2004 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
06/05/2020 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/13/2012 SUPPL-1 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

LORAZEPAM

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATIVAN LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription Yes AP 018140 HIKMA
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 075025 AKORN
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 074243 HOSPIRA
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 074282 HOSPIRA
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 076150 INTL MEDICATION SYS

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