Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018654
Company: HLR
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VERSED MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
VERSED MIDAZOLAM HYDROCHLORIDE EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
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.

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