Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017658
Company: ACTAVIS LABS UT INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LOXITANE C LOXAPINE HYDROCHLORIDE EQ 25MG BASE/ML CONCENTRATE;ORAL 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
05/04/1976 ORIG-1 Approval Type 2 - New Active Ingredient 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-38 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
09/26/2000 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

10/10/2000 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/16/1998 SUPPL-35 Labeling

Label is not available on this site.

01/28/1998 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/28/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/21/1994 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

06/29/1994 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

03/29/1994 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/16/1990 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/03/1987 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

11/30/1984 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/10/1983 SUPPL-18 Labeling

Label is not available on this site.

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

Label is not available on this site.

09/13/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/26/1981 SUPPL-15 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/03/1981 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/14/1981 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

10/08/1981 SUPPL-12 Labeling

Label is not available on this site.

01/06/1981 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/24/1979 SUPPL-10 Labeling

Label is not available on this site.

09/16/1980 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

10/11/1977 SUPPL-7 Labeling

Label is not available on this site.

06/03/1977 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1977 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1977 SUPPL-3 Manufacturing (CMC)-Formulation

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-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017525s051,017658s038,018039s024lbl.pdf

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