Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018039
Company: ACTAVIS LABS UT INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOXITANE IM LOXAPINE HYDROCHLORIDE EQ 50MG BASE/ML INJECTABLE;INJECTION Discontinued None 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
10/26/1979 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-24 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017658Orig1s038,018039Orig1s024,017525Orig1s051ltr.pdf
09/16/1998 SUPPL-23 Labeling

Label is not available on this site.

11/21/1994 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1994 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/03/1987 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/20/1984 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1983 SUPPL-7 Labeling

Label is not available on this site.

10/17/1983 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/08/1981 SUPPL-5 Labeling

Label is not available on this site.

02/20/1980 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/06/1981 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

09/16/1980 SUPPL-2 Labeling

Label is not available on this site.

09/16/1980 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/23/2017 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf

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