Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017604
Company: XSPIRE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALFON FENOPROFEN CALCIUM EQ 300MG BASE CAPSULE;ORAL Discontinued None No No
NALFON FENOPROFEN CALCIUM EQ 200MG BASE CAPSULE;ORAL Prescription None Yes No
NALFON FENOPROFEN CALCIUM EQ 400MG BASE CAPSULE;ORAL Prescription None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/16/1976 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/09/2016 SUPPL-46 Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017604Orig1s046ltr.pdf
07/21/2009 SUPPL-43 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017604s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017604s043ltr.pdf
08/07/2007 SUPPL-41 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017604s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017604s041ltr.pdf
01/18/2006 SUPPL-40 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017604s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017604s040ltr.pdf
08/21/2001 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1999 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

09/30/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

04/02/1998 SUPPL-33 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/22/1997 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

01/22/1996 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/29/1995 SUPPL-27 Labeling

Label is not available on this site.

07/15/1987 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1987 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/09/1986 SUPPL-22 Labeling

Label is not available on this site.

12/11/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/31/1983 SUPPL-18 Labeling

Label is not available on this site.

07/29/1983 SUPPL-17 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/09/1983 SUPPL-16 Labeling

Label is not available on this site.

07/14/1981 SUPPL-15 Labeling

Label is not available on this site.

05/06/1980 SUPPL-14 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/09/1983 SUPPL-13 Labeling

Label is not available on this site.

10/15/1980 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/15/1980 SUPPL-9 Efficacy

Label is not available on this site.

10/24/1978 SUPPL-7 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

04/01/1977 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1976 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/09/2016 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf
05/09/2016 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf
05/09/2016 SUPPL-46 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017604s046lbl.pdf
07/21/2009 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017604s043lbl.pdf
07/21/2009 SUPPL-43 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017604s043lbl.pdf
08/07/2007 SUPPL-41 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/017604s041lbl.pdf
01/18/2006 SUPPL-40 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/017604s040lbl.pdf

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