Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017835
Company: ISO TEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHROMALBIN ALBUMIN CHROMATED CR-51 SERUM 100uCi/VIAL INJECTABLE;INJECTION Discontinued None No No
CHROMALBIN ALBUMIN CHROMATED CR-51 SERUM 250uCi/VIAL INJECTABLE;INJECTION Discontinued None No No
CHROMALBIN ALBUMIN CHROMATED CR-51 SERUM 500uCi/VIAL INJECTABLE;INJECTION 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
02/23/1976 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/17/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/29/1981 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/08/1979 SUPPL-6 Labeling

Label is not available on this site.

03/08/1979 SUPPL-5 Labeling

Label is not available on this site.

02/28/1978 SUPPL-4 Labeling

Label is not available on this site.

02/28/1978 SUPPL-2 Labeling

Label is not available on this site.

07/16/1976 SUPPL-1 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