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AREDIA

NDA

PAMIDRONATE DISODIUM | N020036 | NOVARTIS PHARMACEUTICALS CORP

3 strengths0 unique patents0 unique exclusivities

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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

16 letters from Drugs@FDA

Date	Submission	Document
Jun 7, 2012	SUPPL -41	View Letter (PDF)
Apr 4, 2011	SUPPL -39	View Letter (PDF)
Dec 18, 2008	SUPPL -35	View Letter (PDF)
Jan 9, 2008	SUPPL -34	View Letter (PDF)
Nov 18, 2005	SUPPL -32	View Letter (PDF)
Oct 14, 2005	SUPPL -31	View Letter (PDF)
Feb 3, 2005	SUPPL -30	View Letter (PDF)
Sep 10, 2004	SUPPL -4	View Letter (PDF)
Mar 28, 2004	SUPPL -29	View Letter (PDF)
Jan 9, 2004	SUPPL -28	View Letter (PDF)
Dec 2, 2003	ORIG -1	View Letter (PDF)
Oct 16, 2003	SUPPL -20	View Letter (PDF)
Jul 12, 2002	SUPPL -26	View Letter (PDF)
Aug 20, 2001	SUPPL -24	View Letter (PDF)
Sep 22, 1998	SUPPL -15	View Letter (PDF)
Sep 22, 1998	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 31, 1991

No patent or exclusivity listings for this strength.

#003 — 60MG/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 6, 1993

#004 — 90MG/VIAL

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: May 6, 1993