Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 018654
Company: HLR

Products on NDA 018654

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VERSED	MIDAZOLAM HYDROCHLORIDE	EQ 5MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
VERSED	MIDAZOLAM HYDROCHLORIDE	EQ 1MG BASE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018654

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/20/1985	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018654Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/04/2001	SUPPL-38	Labeling		Label is not available on this site.
12/20/1999	SUPPL-37	Manufacturing (CMC)-Control		Label is not available on this site.
08/25/1998	SUPPL-36	Labeling		Label is not available on this site.
12/17/1998	SUPPL-33	Manufacturing (CMC)-Control		Label is not available on this site.
10/23/1998	SUPPL-32	Manufacturing (CMC)-Control		Label is not available on this site.
05/11/1998	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
03/18/1997	SUPPL-30	Efficacy-New Dosing Regimen	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018654ap.pdf
12/31/1996	SUPPL-29	Efficacy-New Dosing Regimen	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018654ap.pdf
02/19/1999	SUPPL-28	Labeling		Label is not available on this site.
04/26/1994	SUPPL-27	Efficacy-New Indication		Label is not available on this site.
07/06/1995	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
07/22/1993	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
02/19/1999	SUPPL-24	Labeling		Label is not available on this site.
02/26/1993	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
02/26/1993	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
03/12/1993	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
09/19/1991	SUPPL-20	Labeling		Label is not available on this site.
12/31/1996	SUPPL-18	Labeling	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/018654ap.pdf
10/04/1990	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
10/04/1990	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
09/19/1991	SUPPL-15	Labeling		Label is not available on this site.
09/29/1989	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
02/25/1988	SUPPL-12	Labeling		Label is not available on this site.
08/20/1987	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/26/1987	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
05/26/1987	SUPPL-9	Labeling		Label is not available on this site.
02/25/1987	SUPPL-8	Labeling		Label is not available on this site.
10/17/1988	SUPPL-5	Labeling		Label is not available on this site.
05/28/1986	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
05/28/1986	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.