Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 085497
Company: VIRTUS PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE 35MG 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
08/19/1977 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
03/18/1991 SUPPL-15 Labeling

Label is not available on this site.

07/19/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/19/1995 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/24/1989 SUPPL-11 Labeling

Label is not available on this site.

06/14/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/12/1982 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/19/1982 SUPPL-4 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