Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075025
Company: AKORN
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
07/23/1998 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75025_Lorazepam.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/27/2017 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

08/30/2005 SUPPL-4 Labeling

Label is not available on this site.

04/28/2000 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

03/05/2001 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/07/1999 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

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