Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 074410
Company: CHARTWELL MOLECULES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NAPROXEN NAPROXEN 250MG TABLET;ORAL Discontinued None No No
NAPROXEN NAPROXEN 375MG TABLET;ORAL Discontinued None No No
NAPROXEN NAPROXEN 500MG TABLET;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
04/28/1995 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/09/2017 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

02/17/2006 SUPPL-14 Labeling

Label is not available on this site.

01/31/2006 SUPPL-13 Labeling

Label is not available on this site.

11/19/2002 SUPPL-8 Labeling

Label is not available on this site.

11/19/2002 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/19/2002 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

08/27/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

10/09/2001 SUPPL-4 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

10/09/2001 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

11/24/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

03/04/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English