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LEVOLEUCOVORIN CALCIUM

ANDA

LEVOLEUCOVORIN CALCIUM | A210623 | INGENUS PHARMACEUTICALS LLC

2 strengths0 unique patents0 unique exclusivities

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.

Products (2)

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

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 3, 2018

No patent or exclusivity listings for this strength.

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

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: May 3, 2018

Change History (4)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

INGENUS PHARMS LLC replaced NOVAST LABS as the applicant for levoleucovorin calcium (NDA 210623).

Old: NOVAST LABS

New: INGENUS PHARMS LLC

MODIFIEDApplicant Full Name7/1/2026

INGENUS PHARMACEUTICALS LLC acquired the NDA for levoleucovorin calcium (NDA 210623) from NOVAST LABORATORIES LTD, as reflected by the applicant change in the FDA Orange Book.

Old: NOVAST LABORATORIES LTD

New: INGENUS PHARMACEUTICALS LLC