Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 017776
Company: JUBILANT DRAXIMAGE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PULMOLITE TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT N/A INJECTABLE;INJECTION Discontinued None Yes 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
11/16/1976 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
07/30/2002 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

05/24/2001 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/15/2000 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

02/07/2000 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

07/13/1999 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

10/01/1997 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1995 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/19/1989 SUPPL-9 Labeling

Label is not available on this site.

05/03/1985 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1992 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1983 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1985 SUPPL-5 Labeling

Label is not available on this site.

07/24/1980 SUPPL-4 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