Viewing data from:

CALCIUM CHLORIDE 10%

ANDA

CALCIUM CHLORIDE | A217463 | SQUARE PHARMACEUTICALS PLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER(TE code: AP)

API Supply Chain3 active DMFs

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

MACCO ORGANIQUES SROCALCIUM CHLORIDE DIHYDRATE USP

DMF 149962000

MERCK KGAACALCIUM CHLORIDE DIHYDRATE

DMF 185022005

CFL CHEMISCHE FABRIK LEHRTE GMBH AND CO KGCALCIUM CHLORIDE DIHYDRATE

DMF 370592022

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

Products (1)

#001 — 100MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 29, 2025

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

CALCIUM CHLORIDE 10% (calcium chloride) by SQUARE PHARMS PLC changed from discontinued to active prescription-drug status in the FDA database.

Old: DISCN

New: RX

MODIFIEDTE Code7/1/2026

Square Pharma's Calcium Chloride 10% (NDA 217463) received an AP therapeutic equivalence rating, indicating FDA approval as therapeutically equivalent to reference-listed drugs.

New: AP