Viewing data from:

TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT

BLA

TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT | B017881 | DRAXIMAGE

1 product0 Purple Book patents

Biologic LOENo LOE data

No exclusivity dates or listed patents found in Purple Book

Purple Book Patents

No listed patents in Purple Book.

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 17881

351(a) ReferenceLicensedCDERFor Injectable Suspension

Proper Name

kit for the preparation of technetium Tc-99m albumin aggregated

Applicant

Jubilant DraxImage Inc.

Approval Date

30-Dec-87

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — N/A

▴

INJECTABLE;INJECTION | Approved: 1987-12-30 00:00:00

No patent or exclusivity listings for this strength.