FDA Approval Activities for this Drug…

Avita Gel (tretinoin gel), 0.025% Penederm NDA 20-400 Renova (tretionin) Cream, 0.02%, Johnson and Johnson Consumer Industries, NDA 21-108/S1 7/14/02 7/15/02 7/15/02 Renova (tretionin) Cream, 0.02%, Johnson and Johnson Consumer Industries, NDA 21-108 8/31/00 9/11/00 9/11/00 Renova Indications: For the mitigation (palliation) of fine facial wrinkles in patients who use comprehensive skin care and sunlight avoidance programs. Renova (tretionin) Cream, 0.05%, Johnson and Johnson Consumer Industries, NDA 19-963/SE8-005 & SLR-007 8/1/00 8/9/00 8/9/00 Renova Indications:An adjunctive agent for the use in mitigation (palliation) of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who use comprehensive skin care and sunlight avoidance programs. Retin-A (tretinoin) Liquid, Cream, 0.1%, Cream, 0.05%, Gel, 0.025%, Gel, 0.01%, and Cream, 0.025%., Johnson & Johnson Consumer Companies, NDA 16-921 S021/022/025, 17-340 S032/033/036, 17-522 S022/023/026, 17-579 S018/020/023, 17-955 S019/020/023, & 19-049 S007/008/011 6/10/02 6/14/02 6/12/02 Retin-A MICRO (tretinoin gel) microspheres, 0.04% Johnson & Johnson Consumer Companies, Inc NDA 20-475/S-008 Tretinoin Cream USP, 0.1%, Spear ANDA 75-213 12/24/98 12/24/98 8/24/01 Tretinoin Cream USP, 0.025%, Spear ANDA 75-264 12/24/98 12/24/98 8/24/01 Tretinoin Cream USP, 0.05%, Spear ANDA 75-265 12/24/98 12/24/98 8/24/01 Tretinoin Gel USP, 0.01%, Spear ANDA 75-589 6/11/02 Tretinoin Gel USP, 0.025%, Spear ANDA 75-529 2/22/00 2/24/00 6/7/01 Tretinoin Topicals Solution USP, 0.05%, Copley ANDA 74-873 6/19/98 6/19/98 3/16/99 Tretinoin Topicals Solution USP, 0.05%, Morton Grove ANDA 75-260 1/25/99 1/25/99 12/26/01 Vesanoid (Tretinoin) Capsules, 10 mg, Roche, NDA 20-438/S1 FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN Cream; Topical 0.01%;4%;0.05% TRI-LUMA HILL DERMAC MEQUINOL; TRETINOIN Solution; Topical 2%;0.01% SOLAGE GALDERMA 020438 TRETINOIN Capsule; 10MG VESANOID ROCHE 019963 TRETINOIN Cream, Augmented; Topical 0.05% RENOVA JOHNSON AND JOHNSON 020404 TRETINOIN Cream; Topical 0.025% AVITA BERTEK 021108 TRETINOIN Cream; Topical 0.02% RENOVA JOHNSON AND JOHNSON 019049 TRETINOIN Cream; Topical 0.025% RETIN-A JOHNSON AND JOHNSON 017522 TRETINOIN Cream; Topical 0.05% RETIN-A JOHNSON AND JOHNSON 017340 TRETINOIN Cream; Topical 0.1% RETIN-A JOHNSON AND JOHNSON 075264 TRETINOIN Cream; Topical 0.025% TRETINOIN SPEAR 075265 TRETINOIN Cream; Topical 0.05% TRETINOIN SPEAR 075213 TRETINOIN Cream; Topical 0.1% TRETINOIN SPEAR 020400 BT TRETINOIN Gel; Topical 0.025% AVITA BERTEK 017955 TRETINOIN Gel; Topical 0.01% RETIN-A JOHNSON AND JOHNSON 017579 TRETINOIN Gel; Topical 0.025% RETIN-A JOHNSON AND JOHNSON 020475 TRETINOIN Gel; Topical 0.04% RETIN-A MICRO JOHNSON AND JOHNSON 020475 TRETINOIN Gel; Topical 0.1% RETIN-A MICRO JOHNSON AND JOHNSON 075589 TRETINOIN Gel; Topical 0.01% TRETINOIN SPEAR 075529 TRETINOIN Gel; Topical 0.025% TRETINOIN SPEAR 074873 AT TRETINOIN Solution; Topical 0.05% TRETINOIN Copley 016921 AT TRETINOIN Solution; Topical 0.05% RETIN-A JOHNSON AND JOHNSON 075260 AT TRETINOIN Solution; Topical 0.05% TRETINOIN Morton Grove | Vesanoid (tretinoin) Capsules, Hoffman-La Roche, Labeling Revision

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