Viewing data from:

Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

AREDIA

NDANot in Orange Book

PAMIDRONATE DISODIUM | N020927 | NOVARTIS

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

GADOR SAPAMIDRONATE DISODIUM

DMF 394422025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 22, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 30MG/VIAL

▴

INJECTABLE; INJECTION | Approved: Sep. 22, 1998

No patent or exclusivity listings for this strength.

#002 — 60MG/VIAL

▾

INJECTABLE;INJECTION | Approved: Sep. 22, 1998

#003 — 90MG/VIAL

▾

INJECTABLE; INJECTION | Approved: Sep. 22, 1998