FDA Approval Activities for this Drug…

Loniten (minoxidil) Tablets, 2.5 and 10 mg, Pharmacia & Upjohn Company NDA 18-154/S-023 Minoxidil Topical Solution, 2% Apotex USA ANDA 74-924 4/29/98 5/6/98 Minoxidil Topical Solution, 5%, Morton Grove ANDA 75-438 2/27/03 Minoxidil Topical Solution, 2% L. Perrigo Company ANDA 75-357 7/30/99 8/4/99 Minoxidil Topical Solution USP, 5% (For Men) Alpharma, U.S. ANDA 75-518 11/17/00 11/27/00 Minoxidil Topical Solution USP, 5% (For Men) (7/22/99) Alpharma, U.S. ANDA 75-518 7/22/99 7/29/99 Minoxidil Topical Solution USP, 5% (For Men), OTC L. Perrigo Company ANDA 75-598 6/13/01 6/26/01 Minoxidil Topical Solution USP, 5% (For Men), OTC (7/24/00) L. Perrigo Company ANDA 75-598 7/24/00 11/7/00 Minoxidil Topical Solution USP (for Men) 5% Solution, OTC Copley Pharmaceutical, Inc ANDA 75-619 11/17/00 11/27/00 Minoxidil Topical Solution USP (for Men) 5% Solution, OTC Novex Pharma ANDA 75-839 10/1/01 1/17/02 1/17/02 Minoxidil Topical Solution USP (for Men) 5% Solution, OTC Clay-Park Labs, ANDA 75-737 3/15/02 4/10/03 Minoxidil Topical Solution USP (for Men) 5% Solution, January 18, 2000, OTC Copley Pharmaceutical, Inc ANDA 75-619 Rogaine for Men Extra Strength (minoxidil topical solution), 5% Pharmacia Consumer Healthcare NDA 20-834/S-003 Rogaine for Men Regular Strength and Rogaine for Women (2% minoxidil) topical solution, Pfizer Rogaine Men's Extra Strength (5% minoxidil) topical solution, Pfizer Theroxidil Extra Strength (Minoxidil) Topical Solution, Harmony Labs, Approval

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