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DRAXIMAGE MDP-10

NDA

TECHNETIUM TC-99M MEDRONATE | N018035 | JUBILANT DRAXIMAGE INC DBA JUBILANT RADIOPHARMA

2 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

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

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Pharmalucence, Inc. FDA-2018-P-2175 Pharmalucence, Inc. filed this citizen petition in June 2018 requesting that the FDA establish therapeutic equivalence between Technetium TC-99m Medronate Kit (Pharmalucence CIS-MDP NDA 018124) and Technetium TC-99m Medronate (DRAXIMAGE MDP-25 NDA 018035) under the Orange Book pursuant to 21 CFR 10.	Other	2018-06-07	Withdrawn	Pharmalucence

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

6 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

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#001 — N/A

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — N/A

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Feb 27, 2004