Viewing data from:

LEUCOVORIN CALCIUM

ANDA

LEUCOVORIN CALCIUM | A072736 | HIKMA PHARMACEUTICALS USA INC

1 strength0 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 (1)

#001 — EQ 25MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 22, 1993

No patent or exclusivity listings for this strength.

Change History (1)

Recent changes detected for this application.

MODIFIEDrs7/1/2026

Hikma's Leucovorin Calcium (NDA 072736) lost its Rx-to-OTC reclassification status, reverting to prescription-only classification.

Old: Yes

New: No