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MEGATOPE

BLA

ALBUMIN IODINATED I-131 SERUM | B017837 | ISO TEX

5 products0 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 17837 | 5 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

iodinated I-131 albumin

Applicant

Iso-Tex Diagnostics, Inc.

Approval Date

23-Feb-76

0.5mCi — Multi-Dose Vial (Intravenous)

1mCi — Multi-Dose Vial (Intravenous)

2mCi — Multi-Dose Vial (Intravenous)

5uCi/AMP — Multi-Dose Vial (Intravenous)

20uCi/AMP — Multi-Dose Vial (Intravenous)

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 28, 2023	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.