Viewing data from:

LEUCOVORIN CALCIUM

ANDA

LEUCOVORIN CALCIUM | A211132 | INGENUS PHARMACEUTICALS LLC

4 strengths0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs4 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

CERBIOS PHARMA SALEUCOVORIN CALCIUM

DMF 50461983

GMT FINE CHEMICALS SALEUCOVORIN CALCIUM

DMF 337402019

HUZHOU ZHANWANG PHARMACEUTICAL CO LTDLEUCOVORIN CALCIUM

DMF 388782023

SICHUAN HUIYU PHARMACEUTICAL CO LTDLEUCOVORIN CALCIUM

DMF 404272024

CYANAMID GMBHInactiveLEUCOVORIN CALCIUM

DMF 37151980

ORION CORP FARMOS CHEMICAL PLANTInactiveLEUCOVORIN CALCIUM 15MG TABLET

DMF 69251987

LABOCHIM SPAInactiveLEUCOVORIN CALCIUM

DMF 102321993

ALP PHARM BEIJING CO LTDInactiveLEUCOVORIN CALCIUM

DMF 253342011

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

Products (4)

Sort:

#001 — EQ 5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 30, 2020

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 30, 2020

#003 — EQ 15MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 30, 2020

#004 — EQ 25MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 30, 2020

Change History (1)

Recent changes detected for this application.

MODIFIEDrs7/1/2026

Ingenus Pharmaceuticals' leucovorin calcium NDA 211132 was designated as a Reference Standard product.

Old: No

New: Yes