Product Approval Information - New Drug Applications
Summary Basis of Approval - ANDA 010228
| Drug Product: | Anticoagulant Citrate Dextrose Solution--Formula A, USP Proprietary Name: None |
| Applicant: | Gambro BCT, Inc. 10811 West Collins Avenue Lakewood, CO 80215-4440 |
| Dosage Form: | Sterile Injection; Not for Direct Intravenous Infusion |
| Dispensed: | Under prescription order (Rx); In 750 mL plastic containers. |
| Intended Use: | Anticoagulant for blood collection. |
| Period of Marketing Exclusivity (re 21 CFR 314.94a(3)ii): | According to the information published in the list of Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), Anticoagulant Citrate Dextrose Solution-Formula A, is not entitled to a period of marketing exclusivity under Section 505(j)4(D) of the Act. |
| Patent Certification and Exclusivity Statement (re 21 CFR 314.94(a)12(B)ii): | In the opinion and to the best knowledge of Gambro BCT, Inc., there are no patents that claim Anticoagulant Citrate Dextrose Solution-Formula A, or that claim a use for Anticoagulant Citrate Dextrose Solution-Formula A. |
| Potency: | ---% to ---% of nominal (labeled) |
| Pharmacological Category: | USP, Anticoagulant |
| Regulatory Status: | The legally marketed drug product is listed as "Anticoagulant Citrate Dextrose Solution Formula -- A (ACDA)" on the list of Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), under the section for Drug Products with Approval under Section 505 Administered by CBER.
The Reference Listed Drug authorization is held by Cutter Bio (N71497) and Travenol Labs (either N10855 or N16918, whichever is Solution A). The Reference Listed Drug is currently marketed by Baxter, Fenwal Division, under Code 4B7891, NDC 0942-0641-04. |
| Chemical Name and Structure: | (C6H8O7) (C6H5Na3O7.-2H2O) (NaH2PO4.-H2O) (C6H12O6.H2O) |