CALCIUM ACETATE | N019976 | FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ROXANE LABORATORIES, INC. v. NOVEL LABORATORIES, INC. et al 2 patentsANDA 20-7525, 77-728calcium acetate | D.N.J. | 2015-07-17 | Terminated 2018-09-18 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Beckloff Associates, Inc. - Withdrawal of Suitability Petition FDA-2008-P-0175 Beckloff Associates, Inc. filed a petition on March 13, 2008, requesting that the FDA declare Calcium Acetate Oral Solution, 667 mg/5 mL, suitable for submission as an ANDA, with PhosLo Tablets, 667 mg (NDA 019976) as the reference listed drug. Beckloff Associates withdrew this suitability petition | Suitability | 2009-01-30 | Open | — |
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Food, Drug and Cosmetic Act, using PhosLo (calcium acetate) Tablets, 667 mg, approved under N | 505(q) | 2008-11-13 | Withdrawn | — |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.
No patent or exclusivity listings for this strength.