Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 200217
Company: SAGENT AGILA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription AP No No
LORAZEPAM LORAZEPAM 4MG/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
04/04/2017 ORIG-1 Approval Not Applicable

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 WEST-WARD PHARMS INT
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
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 200217 SAGENT AGILA LLC
LORAZEPAM LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 200542 SAGENT AGILA LLC
LORAZEPAM PRESERVATIVE FREE LORAZEPAM 2MG/ML INJECTABLE;INJECTION Prescription No AP 077074 BEDFORD LABS

INJECTABLE;INJECTION; 4MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ATIVAN LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription Yes AP 018140 WEST-WARD PHARMS INT
LORAZEPAM LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription No AP 074243 HOSPIRA
LORAZEPAM LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription No AP 074282 HOSPIRA
LORAZEPAM LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription No AP 200217 SAGENT AGILA LLC
LORAZEPAM LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription No AP 200542 SAGENT AGILA LLC
LORAZEPAM PRESERVATIVE FREE LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription No AP 077074 BEDFORD LABS

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