RETIN-A

FDA-2010-P-0157 · 6 docket documents

Rakoczy Molino Mazzochi Siwik LLP filed this citizen petition on March 17, 2010, requesting that the FDA determine whether Hoffman-La Roche voluntarily withdrew VESANOID (Tretinoin) Capsules, 10 mg, from the market for reasons unrelated to safety or effectiveness, and if so, permit abbreviated new d

FDA-2003-P-0015 · 8 docket documents

Jerussi Consulting, Inc. filed this suitability petition on August 11, 2003, requesting that the FDA determine that a topical solution containing 4% hydroquinone and 0.01% tretinoin can be substituted for the approved formulation of Solage (NDA #20-922), which contains 2% mequinol and 0.01% tretinoi

FDA-2006-P-0267 · 5 docket documents

E. Tanghetti, MD, filed this petition on December 15, 2006, requesting that the FDA withdraw approval of and recall Ziana, a topical combination product containing clindamycin phosphate 1.2% and tretinoin 0.025%, or alternatively require long-term safety studies to evaluate antibiotic resistance ass

FDA-2008-P-0217 · 4 docket documents

Cobe Chem Labs filed this petition in December 2007 pursuant to 21 CFR 314 to request FDA permission to submit an Abbreviated New Drug Application for a generic tretinoin cream 0.1%, with Retin-A cream 0.1% (NDA 17-340, approved January 26, 1973) as the reference listed drug, noting that no unexpire