Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 075025
Company: RISING

Products on ANDA 075025

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORAZEPAM	LORAZEPAM	2MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075025

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.

Therapeutic Equivalents for ANDA 075025

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	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	075025	RISING