Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017710
Company: DISTA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NALFON FENOPROFEN CALCIUM EQ 600MG BASE 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
06/09/1977 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
12/22/1997 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/25/1994 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/29/1995 SUPPL-21 Labeling

Label is not available on this site.

07/08/1987 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/04/1988 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/09/1986 SUPPL-12 Labeling

Label is not available on this site.

07/08/1987 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1983 SUPPL-10 Labeling

Label is not available on this site.

12/11/1987 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

08/09/1983 SUPPL-7 Labeling

Label is not available on this site.

02/10/1982 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/10/1982 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/09/1983 SUPPL-4 Labeling

Label is not available on this site.

04/09/1980 SUPPL-3 Manufacturing (CMC)-Formulation

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