Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017525
Company: ACTAVIS LABS UT INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOXITANE LOXAPINE SUCCINATE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
LOXITANE LOXAPINE SUCCINATE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
LOXITANE LOXAPINE SUCCINATE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
LOXITANE LOXAPINE SUCCINATE EQ 50MG BASE *Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
LOXITANE LOXAPINE SUCCINATE EQ 10MG BASE **Federal Register determination that product was discontinued or withdrawn for s or e reasons** TABLET;ORAL Discontinued None Yes No
LOXITANE LOXAPINE SUCCINATE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
LOXITANE LOXAPINE SUCCINATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
02/25/1975 ORIG-1 Approval Type 1 - New Molecular Entity 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-51 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-49 Labeling

Label is not available on this site.

01/28/1997 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

03/25/1996 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

02/27/1995 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/16/1991 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

06/29/1994 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1994 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

07/25/1990 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

07/18/1989 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

04/28/1989 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

02/03/1987 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1986 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/14/1985 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

10/17/1983 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1982 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/19/1983 SUPPL-22 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

03/10/1983 SUPPL-21 Efficacy

Label is not available on this site.

10/08/1981 SUPPL-20 Labeling

Label is not available on this site.

10/08/1981 SUPPL-19 Labeling

Label is not available on this site.

01/06/1981 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/24/1979 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/16/1980 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

11/08/1979 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

06/08/1978 SUPPL-13 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/25/1978 SUPPL-12 Labeling

Label is not available on this site.

06/08/1978 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/23/1976 SUPPL-9 Labeling

Label is not available on this site.

10/25/1977 SUPPL-8 Labeling

Label is not available on this site.

11/30/1976 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/04/1976 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1976 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1976 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1977 SUPPL-2 Manufacturing (CMC)-Control

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-51 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf

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