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PEMETREXED DITROMETHAMINE

NDA

PEMETREXED DITROMETHAMINE | N208746 | HOSPIRA INC

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

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.

DR REDDYS LABORATORIES LTDPEMETREXED DITROMETHAMINE DIHYDRATE

DMF 283162014

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 13, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 100MG BASE/VIAL

RLD

0 patents0 exclusivities▴

POWDER;INTRAVENOUS | Approved: Jun 10, 2022

No patent or exclusivity listings for this strength.

#002 — EQ 500MG BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Jun 10, 2022

#003 — EQ 1GM BASE/VIAL

RLD

0 patents0 exclusivities▾

POWDER;INTRAVENOUS | Approved: Jun 10, 2022