PHOSLO

FDA-2013-P-0040 · 3 docket documents

Lupin Pharmaceuticals, Inc. filed this citizen petition pursuant to 21 CFR 10.30 and 21 CFR 314.94 requesting that the FDA amend the Orange Book to designate Roxane's Calcium Acetate Capsules as a second reference listed drug for Calcium Acetate Capsules, citing that the current reference listed dru

FDA-2011-P-0115 · 5 docket documents

Cypress Pharmaceutical, Inc. filed this suitability petition in February 2011 requesting that the FDA declare Calcium Acetate Oral Solution, 667 mg/5 mL, suitable for submission as an ANDA, with PhosLo (calcium acetate) Gelcaps, 667 mg, approved under NDA 021160, as the reference listed drug. The pe

FDA-2006-P-0327 · 6 docket documents

Beckloff Associates filed this citizen petition on behalf of a client requesting that the FDA determine whether PhosLo (calcium acetate) Tablets and Capsules, both containing 169 mg calcium equivalent and approved under NDA Nos. 019-976 and 021-160 respectively, were withdrawn from sale for safety o

FDA-2006-P-0445 · 6 docket documents

Lachman Consultant Services, Inc., on behalf of a client, filed a citizen petition requesting that the FDA determine whether Phoslo (calcium acetate) Tablets, equivalent to 169 mg calcium, approved under NDA 19-976, were voluntarily withdrawn from sale for safety or effectiveness reasons, as the inn

FDA-2006-P-0446 · 4 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of an unnamed client requesting that the FDA determine whether Phoslo (calcium acetate) Capsules equivalent to 169 mg calcium, approved under NDA 21-160, was voluntarily withdrawn from sale for reasons of safety or effectiveness, as the