Last Updated: November 8, 2026

Details for New Drug Application (NDA): 201658

« Back to Dashboard

NDA 201658 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 201658

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

Pharmacology for NDA: 201658

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

Suppliers and Packaging for NDA: 201658

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	201658	ANDA	Amneal Pharmaceuticals of New York LLC	53746-590	53746-590-01	100 CAPSULE in 1 BOTTLE (53746-590-01)
CALCIUM ACETATE	calcium acetate	CAPSULE;ORAL	201658	ANDA	Amneal Pharmaceuticals of New York LLC	53746-590	53746-590-05	500 CAPSULE in 1 BOTTLE (53746-590-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	667MG
Approval Date:	Oct 6, 2014	TE:		RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.