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FDA Approval Activities for this Drug…
Flagyl 375 (metronidazole) Capsules, Pharmacia NDA 20-334/S-001 4/23/03 Flagyl ER (metronidazole) Extended-Release Capsules, Pharmacia NDA 20-868/S5 4/23/03 Flagyl (metronidazole) tablets, Pharmacia NDA 12-623/S-058 MetroGel (metronidazole) Topical Gel, 0.75% Galderma , L. P. NDA 19-737/S7 6/3/02 6/14/02 MetroLotion (metronidazole) Topical Lotion, 0.75% Galderma , NDA 20-901 11/24/98 11/24/98 11/24/98 7/8/99 MetroLotion Indication: Treatment of inflammatory papules and pustules of rosacea. Metronidazole Tablets, 250 & 500mg, Able ANDA 76-519 6/27/03 Metronidazole Extended-release Tablets, 750mg, Able ANDA 76-462 Noritate (metronidazole cream) Cream, 1%, Dermik NDA 20-743/S002 BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE Tablet, Chewable, Tablet, Capsule; 262.4MG;250MG;500MG HELIDAC Prometheus 020334 METRONIDAZOLE Capsule; 375MG FLAGYL GD SEARLE 020743 METRONIDAZOLE Cream; Topical 1% NORITATE DERMIK 020531 METRONIDAZOLE Cream; Topical 0.75% METROCREAM GALDERMA LP 019737 METRONIDAZOLE Gel; Topical 0.75% METROGEL GALDERMA LP 020208 METRONIDAZOLE Gel; Vaginal 0.75% METROGEL-VAGINAL 3M 018890 METRONIDAZOLE Injection 500MG/100ML METRONIDAZOLE IN PLASTIC CONTAINER Abbott 018900 METRONIDAZOLE Injection 500MG/100ML METRO I.V. IN PLASTIC CONTAINER B BRAUN 018657 METRONIDAZOLE Injection 500MG/100ML FLAGYL I.V. RTU IN PLASTIC CONTAINER Baxter 018353 METRONIDAZOLE Injection 500MG/100ML FLAGYL I.V. RTU IN PLASTIC CONTAINER GD SEARLE 020901 METRONIDAZOLE Lotion; Topical 0.75% METROLOTION GALDERMA LP 076462 METRONIDAZOLE Tablet, Extended Release; 750MG METRONIDAZOLE Able 020868 METRONIDAZOLE Tablet, Extended Release; 750MG FLAGYL ER GD SEARLE 076519 METRONIDAZOLE Tablet; 250MG METRONIDAZOLE Able 076519 METRONIDAZOLE Tablet; 500MG METRONIDAZOLE Able 018620 METRONIDAZOLE Tablet; 250MG METRONIDAZOLE Eon 018620 METRONIDAZOLE Tablet; 500MG METRONIDAZOLE Eon 012623 METRONIDAZOLE Tablet; 250MG FLAGYL GD SEARLE 012623 METRONIDAZOLE Tablet; 500MG FLAGYL GD SEARLE 018740 METRONIDAZOLE Tablet; 250MG METRONIDAZOLE Geneva 018740 METRONIDAZOLE Tablet; 500MG METRONIDAZOLE Geneva 018517 METRONIDAZOLE Tablet; 250MG METRONIDAZOLE Ivax 018517 METRONIDAZOLE Tablet; 500MG METRONIDAZOLE Ivax 074523 METRONIDAZOLE Tablet; 250MG METROMIDOL 074523 METRONIDAZOLE Tablet; 500MG METROMIDOL 019029 METRONIDAZOLE Tablet; 250MG METRONIDAZOLE LNK 070772 METRONIDAZOLE Tablet; 250MG METRONIDAZOLE Mutual 070773 METRONIDAZOLE Tablet; 500MG METRONIDAZOLE Mutual 070040 METRONIDAZOLE Tablet; 250MG METRONIDAZOLE Par 018845 METRONIDAZOLE Tablet; 250MG METRONIDAZOLE Par 070039 METRONIDAZOLE Tablet; 500MG METRONIDAZOLE Par 018930 METRONIDAZOLE Tablet; 500MG METRONIDAZOLE Par 070027 METRONIDAZOLE Tablet; 250MG METRONIDAZOLE Pliva 070033 METRONIDAZOLE Tablet; 500MG METRONIDAZOLE Pliva 070035 METRONIDAZOLE Tablet; 250MG METRONIDAZOLE Teva 070044 METRONIDAZOLE Tablet; 500MG METRONIDAZOLE Teva 018764 METRONIDAZOLE Tablet; 250MG METRONIDAZOLE Watson 018764 METRONIDAZOLE Tablet; 500MG METRONIDAZOLE Watson 018353 METRONIDAZOLE HYDROCHLORIDE Injection 500MG BASE/VIAL FLAGYL I.V. GD SEARLE Metronidazole Capsules, Able Metronidazole Capsules, Kali Laboratories Flagyl (metronidazole), Pfizer Flagyl 375 (metronidazole), Pfizer Flagyl ER (metronidazole), Pfizer MetroLotion (metronidazole lotion) Topical Lotion, Galderma Laboratories Metronidazole Topical Cream, Altana Noritate (metronidazole cream) Cream, Dermik Laboratories, Package Change | Helidac Therapy (bismuth subsalicylate/metronidazole/tetracycline hydrochloride), Prometheus Laboratories, Labeling Revision | Helidac Therapy (bismuth subsalicylate/metronidazole/tetracycline hydrochloride), Prometheus Laboratories, Labeling Revision | Metronidazole Vaginal Gel, Teva Pharma, Approval | METROGEL (metronidazole gel), Dow Pharma, Approval | Metronidazole Topical Gel, Altana, Tentative Approval | METROGEL (metronidazole gel), Galderma Labs, Labeling Revision | Metronidazole Topical Lotion, Altana, Approval | Metronidazole Topical Gel, Altana Inc., Approval | Metronidazole Topical Gel, QLT Inc., Approval | Metronidazole Topical Gel, Taro Pharma, Approval | Pylera (biskalcitrate, metronidazole, and tetracycline hydrochloride) Capsules, Axcan Scandipharm, Approval | Metronidazole Vaginal Gel, QLT Inc., Approval | Pylera Capsules, Axcan Scandipharm, Package Change | HELIDAC Therapy, Prometheus Labs, Labeling Revision | Metronidazole, Topical Cream, G & W Laboratories, Approval | Metronidazole in Plastic Container Injection, Claris LifeSciences, Approval | Helidac (bismuth subsalicylate, metronidazole and tetracycline hydrochloride) Capsules, Chewable Tablets and Tablets, Prometheus Laboratories, Inc., Labeling Revision
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