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Generated: December 11, 2018

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Details for New Drug Application (NDA): 202315

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NDA 202315 describes CALCIUM ACETATE, which is a drug marketed by Amneal Pharms, Chartwell Rx, Heritage Pharms Inc, Invagen Pharms, Lotus Pharm Co Ltd, Lupin Ltd, Nostrum Labs Inc, West-ward Pharms Int, and Paddock Llc, and is included in twelve NDAs. It is available from twenty-eight 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 seventy-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.
Summary for 202315
Tradename:CALCIUM ACETATE
Applicant:Heritage Pharms Inc
Ingredient:calcium acetate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 202315
Suppliers and Packaging for NDA: 202315
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CALCIUM ACETATE calcium acetate CAPSULE;ORAL 202315 ANDA Heritage Pharmaceuticals Inc. 23155-531 23155-531-02 200 CAPSULE in 1 BOTTLE (23155-531-02)
CALCIUM ACETATE calcium acetate CAPSULE;ORAL 202315 ANDA Heritage Pharmaceuticals Inc. 23155-531 23155-531-10 1000 CAPSULE in 1 BOTTLE (23155-531-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength667MG
Approval Date:Jun 29, 2015TE:ABRLD:No

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