Last Updated: November 8, 2026

Details for New Drug Application (NDA): 203135

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NDA 203135 describes CALCIUM ACETATE, which is a drug marketed by Adaptis, Amneal Pharms, Chartwell Rx, Cohance Lifesciences, Heritage Pharms Inc, Hikma, Invagen Pharms, Lotus Pharm Co Ltd, Lupin, Mpp Pharma, Chartwell Molecular, and Padagis Us, and is included in fourteen NDAs. It is available from twenty suppliers. Additional details are available on the CALCIUM ACETATE profile page.

The generic ingredient in CALCIUM ACETATE is calcium acetate. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.

Summary for 203135

Tradename:	CALCIUM ACETATE
Applicant:	Invagen Pharms
Ingredient:	calcium acetate
Patents:	0

Pharmacology for NDA: 203135

Mechanism of Action	Phosphate Chelating Activity
Physiological Effect	Increased Coagulation Factor Activity

Suppliers and Packaging for NDA: 203135

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	203135	ANDA	American Health Packaging	60687-589	60687-589-65	50 BLISTER PACK in 1 CARTON (60687-589-65) / 1 CAPSULE in 1 BLISTER PACK (60687-589-11)
CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	203135	ANDA	Cipla USA Inc.,	69097-862	69097-862-03	60 CAPSULE in 1 BOTTLE (69097-862-03)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	667MG
Approval Date:	Feb 7, 2013	TE:	AB	RLD:	No

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