Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 074243
Company: HOSPIRA
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
04/12/1994 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
05/13/2014 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

04/27/2007 SUPPL-6 Labeling

Label is not available on this site.

03/05/2002 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/14/2001 SUPPL-4 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

04/21/1999 SUPPL-3 Labeling

Label is not available on this site.

04/21/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/22/1995 SUPPL-1 Manufacturing (CMC)-Microbiology-Processing

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

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 HIKMA
LORAZEPAM LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription No AP 074243 HOSPIRA
LORAZEPAM LORAZEPAM 4MG/ML INJECTABLE;INJECTION Prescription No AP 074282 HOSPIRA

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