Details for New Drug Application (NDA): 211038

NDA 211038 describes CALCIUM ACETATE, which is a drug marketed by Amneal Pharms, Chartwell Rx, Heritage Pharms Inc, Hikma, Invagen Pharms, Lotus Pharm Co Ltd, Lupin Ltd, Nostrum Labs Inc, Square Pharms, Suven Pharms, 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 are two hundred and eighty-two drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.

Summary for 211038

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

Pharmacology for NDA: 211038

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

Suppliers and Packaging for NDA: 211038

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	211038	ANDA	Rising Pharma Holdings, Inc.	16571-813	16571-813-20	200 CAPSULE in 1 BOTTLE, PLASTIC (16571-813-20)
CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	211038	ANDA	Suven Pharmaceuticals Limited	68022-0119	68022-0119-1	1 CAPSULE in 1 BOTTLE, PLASTIC (68022-0119-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	667MG
Approval Date:	Feb 21, 2020	TE:	AB	RLD:	No

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