Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 085756
Company: CAMALL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAM-METRAZINE 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
05/11/1977 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
11/09/1988 SUPPL-18 Labeling

Label is not available on this site.

06/27/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/24/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/07/1983 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/03/1983 SUPPL-10 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