Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 010799
Company: WYETH CONS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIMETANE BROMPHENIRAMINE MALEATE 4MG TABLET;ORAL Discontinued None No No
DIMETANE BROMPHENIRAMINE MALEATE 8MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
DIMETANE BROMPHENIRAMINE MALEATE 12MG TABLET, EXTENDED RELEASE;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
08/23/1957 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
04/14/1998 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

04/30/1996 SUPPL-71 Labeling

Label is not available on this site.

02/06/1996 SUPPL-70 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1992 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1989 SUPPL-68 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1989 SUPPL-67 Labeling

Label is not available on this site.

03/24/1988 SUPPL-66 Manufacturing (CMC)-Control

Label is not available on this site.

03/17/1988 SUPPL-65 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1986 SUPPL-64 Labeling

Label is not available on this site.

06/10/1986 SUPPL-63 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1985 SUPPL-62 Manufacturing (CMC)-Control

Label is not available on this site.

06/24/1985 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1984 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

12/19/1984 SUPPL-58 Manufacturing (CMC)-Control

Label is not available on this site.

04/15/1983 SUPPL-57 Efficacy

Label is not available on this site.

04/15/1983 SUPPL-56 Manufacturing (CMC)-Control

Label is not available on this site.

08/17/1984 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1986 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

09/04/1986 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1983 SUPPL-35 Labeling

Label is not available on this site.

06/10/1983 SUPPL-34 Manufacturing (CMC)-Control

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