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LEVOLEUCOVORIN CALCIUM

ANDA

LEVOLEUCOVORIN CALCIUM | A203576 | PHARMOBEDIENT CONSULTING LLC

2 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Spectrum Pharmaceuticals Inc et al v. InnoPharma Inc. 1:2012cv00260 1 patentANDA 203576levoleucovorin	D. Del.	2012-03-02	Terminated 2015-08-04	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain1 active DMF

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

GMT FINE CHEMICALS SALEVOLEUCOVORIN CALCIUM

DMF 251982011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Oct 22, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Oct 20, 2015

No patent or exclusivity listings for this strength.

#002 — EQ 250MG BASE/25ML (EQ 10MG BASE/ML)

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Oct 20, 2015