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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 | Tretinoin Cream, Spear Pharma, Approval | ZIANA (clindamycin phosphate and tretinoin) Gel., Medicis Pharma, Approval | Solagé (mequinol and tretinoin) Topical Solution, Barrier Therapeutics, Efficacy Supp. w/Clinical Data | Tretinoin Capsules, Barr Labs, Approval
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