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PHOSLO

NDA

CALCIUM ACETATE | N021160 | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Beckloff Associates, Inc. - Citizen Pettition FDA-2008-P-0175 Beckloff Associates, Inc. filed this citizen petition requesting that the FDA declare Calcium Acetate Oral Solution, 667 mg/5 mL, suitable for submission as an ANDA under Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act, using PhosLo (calcium acetate) Tablets, 667 mg, approved under N	505(q)	2008-11-13	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain6 active DMFs1 inactive

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

NIACET BVCALCIUM ACETATE

DMF 189972005

VASA PHARMACHEM PVT LTDCALCIUM ACETATE

DMF 225502009

SUVEN LIFE SCIENCES LTDCALCIUM ACETATE USP

DMF 227522009

MACCO ORGANIQUES INCCALCIUM ACETATE

DMF 291662015

GLOBAL CALCIUM PRIVATE LTDCALCIUM ACETATE USP

DMF 356342021

LUOYANG LONGMEN PHARMACEUTICAL CO LTDCALCIUM ACETATE

DMF 426662025

FORMOSA LABORATORIES INCInactiveCALCIUM ACETATE USP

DMF 237352010

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 31, 2011	SUPPL -15	View Letter (PDF)
Mar 2, 2004	SUPPL -1	View Letter (PDF)
Apr 2, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 333.5MG

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 2, 2001

No patent or exclusivity listings for this strength.

#002 — 667MG

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 2, 2001

#003 — 667MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 2, 2001