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FDA Approval Activities for this Drug…
Cleocin Phosphate. (clindamycin injection, USP) sterile solution, Pharmacia & Upjohn Company NDA 50-441/S-047 11/21/01 7/23/02 5/02/03 Cleocin T (clindamycin phosphate) Topical Solution, Gel, and Topical Lotion, Pharmacia NDA 50-537/S13, 50-600/S02 & 50-615/S03 7/14/02 7/24/02 7/15/02 Cleocin Vaginal Ovules (clindamycin phosphate vaginal suppositories), 100 mg Pharmacia & Upjohn NDA 50-767 8/13/99 9/24/99 9/24/99 7/18/01 Cleocin (Clindamycin Phosphate) Cream, USP, 2% Pharmacia & Upjohn NDA 50-680/S004 8/20/03 08/29/03 8/29/03 Cleocin 3 Vaginal (Clindamycin Phosphate) Cream, USP, 2% Pharmacia & Upjohn NDA 50-680/S002 3/2/98 7/4/99 Cleocin Indications: Treatment of Bacterial Vaginosis Clindamycin Hydrochloride Capsules USP, 300 mg, Watson ANDA 63-083/S15 3/18/03 Clindamycin Dextrose Injection, Abbott ANDA 65-027 6/29/01 1/15/02 Clindamycin Phosphate Lotion, 1% (base) Topical Suspension, Altana, ANDA 65-067 1/31/02 Clindamycin Phosphate Topical Solution USP (Pledgets), 1% (base) Topical Gel, Clay-Park Labs, ANDA 65-049 5/25/00 6/6/00 8/27/03 Clindamycin Phosphate Topical Gel USP, 1% (base) Topical Gel, Altana ANDA 64-160 1/28/00 2/4/00 8/27/03 Clindamycin Phosphate Topical Gel USP, 1% (base) Topical Gel, (Target Research Associate - US Agent NDA 50-782 DUAC (clindamycin, 1% - benzoyl peroxide, 5%) Topical Gel, Stiefel , NDA 50-741/S3 10/20/03 DUAC (clindamycin, 1% - benzoyl peroxide, 5%) Topical Gel, Stiefel , NDA 50-741 DUAC (clindamycin, 1% - benzoyl peroxide, 5%) Topical Gel, Stiefel , BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE Gel; Topical 5%;EQ 1% BASE BENZACLIN DERMIK 050741 BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE Gel; Topical 5%;EQ 1% BASE DUAC STIEFEL 050162 CLINDAMYCIN HYDROCHLORIDE Capsule; 150MG BASE CLEOCIN HCL PHARMACIA AND UPJOHN 050162 CLINDAMYCIN HYDROCHLORIDE Capsule; 300MG BASE CLEOCIN HCL PHARMACIA AND UPJOHN 050162 CLINDAMYCIN HYDROCHLORIDE Capsule; 75MG BASE CLEOCIN HCL PHARMACIA AND UPJOHN 065061 CLINDAMYCIN HYDROCHLORIDE Capsule; 150MG BASE CLINDAMYCIN HCL Ranbaxy 065061 CLINDAMYCIN HYDROCHLORIDE Capsule; 300MG BASE CLINDAMYCIN HCL Ranbaxy 063029 CLINDAMYCIN HYDROCHLORIDE Capsule; 150MG BASE CLINDAMYCIN HCL Teva 063027 CLINDAMYCIN HYDROCHLORIDE Capsule; 75MG BASE CLINDAMYCIN HCL Teva 063083 CLINDAMYCIN HYDROCHLORIDE Capsule; 150MG BASE CLINDAMYCIN HCL Watson 063083 CLINDAMYCIN HYDROCHLORIDE Capsule; 300MG BASE CLINDAMYCIN HCL Watson 062644 CLINDAMYCIN PALMITATE HYDROCHLORIDE For Solution; 75MG BASE/5ML CLEOCIN PHARMACIA AND UPJOHN 050680 CLINDAMYCIN PHOSPHATE Cream; Vaginal 2% BASE CLEOCIN PHARMACIA AND UPJOHN 064160 CLINDAMYCIN PHOSPHATE Gel; Topical 1% BASE CLINDAMYCIN PHOSPHATE Altana 050782 BT CLINDAMYCIN PHOSPHATE Gel; Topical 1% BASE CLINDAGEL GALDERMA LP 050615 CLINDAMYCIN PHOSPHATE Gel; Topical 1% BASE CLEOCIN T PHARMACIA AND UPJOHN 065027 CLINDAMYCIN PHOSPHATE Injection 12MG BASE/ML CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER Abbott 062800 CLINDAMYCIN PHOSPHATE Injection 150MG BASE/ML CLINDAMYCIN PHOSPHATE Abbott 062801 CLINDAMYCIN PHOSPHATE Injection 150MG BASE/ML CLINDAMYCIN PHOSPHATE Abbott 065027 CLINDAMYCIN PHOSPHATE Injection 18MG BASE/ML CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER Abbott 065027 CLINDAMYCIN PHOSPHATE Injection 6MG BASE/ML CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER Abbott 050635 CLINDAMYCIN PHOSPHATE Injection 900MG BASE/100ML CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% AM PARTNERS 050648 CLINDAMYCIN PHOSPHATE Injection 12MG BASE/ML CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER Baxter 062889 CLINDAMYCIN PHOSPHATE Injection 150MG BASE/ML CLINDAMYCIN PHOSPHATE Baxter 050648 CLINDAMYCIN PHOSPHATE Injection 6MG BASE/ML CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER Baxter 050648 CLINDAMYCIN PHOSPHATE Injection 900MG BASE/100ML CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER Baxter 062905 CLINDAMYCIN PHOSPHATE Injection 150MG BASE/ML CLINDAMYCIN PHOSPHATE LOCH 050639 CLINDAMYCIN PHOSPHATE Injection 12MG BASE/ML CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER PHARMACIA AND UPJOHN 062803 CLINDAMYCIN PHOSPHATE Injection 150MG BASE/ML CLEOCIN PHOSPHATE PHARMACIA AND UPJOHN 050441 CLINDAMYCIN PHOSPHATE Injection 150MG BASE/ML CLEOCIN PHOSPHATE PHARMACIA AND UPJOHN 050639 CLINDAMYCIN PHOSPHATE Injection 18MG BASE/ML CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER PHARMACIA AND UPJOHN 050639 CLINDAMYCIN PHOSPHATE Injection 6MG BASE/ML CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER PHARMACIA AND UPJOHN 065067 CLINDAMYCIN PHOSPHATE Lotion; Topical 1% BASE CLINDAMYCIN PHOSPHATE Altana 050600 CLINDAMYCIN PHOSPHATE Lotion; Topical 1% BASE CLEOCIN T PHARMACIA AND UPJOHN 062811 AT CLINDAMYCIN PHOSPHATE Solution; Topical 1% BASE CLINDAMYCIN PHOSPHATE ALPHARMA 064050 AT CLINDAMYCIN PHOSPHATE Solution; Topical 1% BASE CLINDAMYCIN PHOSPHATE Clay Park 064159 AT CLINDAMYCIN PHOSPHATE Solution; Topical 1% BASE CLINDAMYCIN PHOSPHATE FOUGERA 063304 AT CLINDAMYCIN PHOSPHATE Solution; Topical 1% BASE CLINDAMYCIN PHOSPHATE Morton Grove 063329 AT CLINDAMYCIN PHOSPHATE Solution; Topical 1% BASE CLINDA-DERM Paddock 050537 AT CLINDAMYCIN PHOSPHATE Solution; Topical 1% BASE CLEOCIN T PHARMACIA AND UPJOHN 064108 AT CLINDAMYCIN PHOSPHATE Solution; Topical 1% BASE CLINDAMYCIN PHOSPHATE STIEFEL 050767 CLINDAMYCIN PHOSPHATE Suppository; Vaginal 100MG CLEOCIN PHARMACIA AND UPJOHN 065049 AT CLINDAMYCIN PHOSPHATE Swab; Topical 1% BASE CLINDAMYCIN PHOSPHATE Clay Park 050537 AT CLINDAMYCIN PHOSPHATE Swab; Topical 1% BASE CLEOCIN PHARMACIA AND UPJOHN 064136 AT CLINDAMYCIN PHOSPHATE Swab; Topical 1% BASE CLINDETS STIEFEL DUAC (clindamycin, 1% - benzoyl peroxide, 5%) Topical Gel, Stiefel Cleocin Phosphate. (clindamycin HCl) Capsules, Injection & sterile solution, Pharmacia & Upjohn Company Clindamycin Hydrochloride Capsules USP, Corepharma Clindamycin Phosphate Topical Solution USP, Taro Pharmaceutical | Clindamycin Injection, Bedford Labs, Approval | Cleocin HCl (clindamycin hydrochloride) Capsules, Pfizer, Inc., Labeling Revision | Cleocin Phosphate (clindamycin injection in 5% dextrose) IV Sterile Solution, Pfizer, Inc., Labeling Revision | Cleocin Phosphate (clindamycin injection, USP) Sterile Solution, Pfizer, Inc., Labeling Revision | Evoclin (clindamycin phosphate) Foam, Connetics Corp, Approval | Clindesse (clindamycin phosphate) Vaginal Cream, KV Pharma, Approval | Clindamycin Phosphate Vaginal Cream, Altana, Approval | Clindamycin Hydrochloride Capsules, Zydus Pharma, Approval BenzaClin (clindamycin & benzoyl peroxide) Topical Gel, Dermik Labs, Labeling Revision | Clindamycin Hydrochloride Capsules, Teva Pharma, New Strength | Clindamycin Hydrochloride Capsules (75 & 150MG), Lannett Holdings, Approval | Clindamycin Hydrochloride Capsules (300MG), Lannett Holdings, Approval | Clindamycin Phosphate Pledgets, Topical Solution, Altana, Approval | ZIANA (clindamycin phosphate and tretinoin) Gel., Medicis Pharma, Approval | Clindamycin Injection, Abraxis Pharma, Approval | Benzaclin (Clindamycin, benzoyl peroxide) Gel, Sanofi-Aventis, Control Supplement | Clindamycin Injection, Abraxis Pharma, Approval | BenzaClin Topical Gel , Sanofi-Aventis, Labeling Revision | Cleocin Phosphate (clindamycin injection) Sterile Solution, Pfizer, Labeling Revision | Cleocin Phosphate (clindamycin in 5% dextrose) IV Sterile Solution, Pfizer, Labeling Revision | Cleocin Phosphate (clindamycin phosphate) Injection, Pfizer, Labeling Revision | Cleocin Phosphate in Dextrose 5% in Plastic Container (clindamycin phosphate) I.V. Sterile Solution, Pfizer, Labeling Revision | Duac (benzoyl peroxide and clindamycin phosphate) Gel, Stiefel Laboratories, Inc., Labeling Revision | Acanya (clindamycin phosphate and benzoyl peroxide) Gel, Dow Pharmaceutical Sciences, Inc., Approval
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