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The FDA's Orange Book identifies approved drug products. FDA has draft guidance explaining that certain currently marketed drug ingredients were marketed before current FDA legislation. Sponsors using these products should consult FDA about the need for an IND.
Orange Book Data File Download Instructions . A step-by-step guide to download the latest Orange Book monthly data to Microsoft Excel on Microsoft Windows*. 1. Go to the Orange Book website’s additional resources and information page found here: Orange Book website
This page searches the Orphan Drug Product designation database. Searches may be run by entering the product name, orphan designation, and dates. Results can be displayed as a condensed list, detailed list, or an Excel spreadsheet. Click for detailed instructions.
This letter is in reference to your abbreviated new drug application (ANDA) received for review on May 28, 2019, submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for Eluxadoline Tablets, 75 mg and 100 mg.
resources such as DRUGS@FDA, the Electronic Orange Book, and the United States Pharmacopeia – National Formulary (USP-NF) online for recent updates, and make any necessary revisions to your labels and labeling.
With respect to 180-day generic drug exclusivity, we note that Mylan was the first ANDA applicant for Breyna (Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol), 160 mcg/4.5 mcg/actuation and 80 mcg/4.5 mcg/actuation, to submit a substantially complete ANDA with a paragraph IV certification. Therefore, with this approval, Mylan ...
Orange Book upon approval of the supplement. You must submit the patent information required by 21 CFR 314.53(d)(2)(i)(A) through (C) and 314.53(d)(2)(ii)(A) and (C), as applicable, to FDA on Form FDA 3542 within 30 days after the date of approval of the supplement for the patent information to be timely filed (see 21 CFR 314.53(c)(2)(ii)).
The Office of Bioequivalence has determined your Dasatinib Tablets, 20 mg, 50 mg, 70 mg, and 100 mg, to be bioequivalent and, therefore, therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets, 20 mg, 50 mg, 70 mg, and 100 mg, of Bristol-Myers Squibb (BMS). Your dissolution testing should be incorporated into the ...
We have determined your Tofacitinib Extended-Release Tablets, 11 mg and 22 mg, to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xeljanz XR, 11 mg and 22 mg, of Pfizer Inc. (Pfizer). The RLD upon which you have based your ANDA, Pfizer’s Xeljanz XR Tablets, 11 mg and 22 mg, is subject to periods of patent ...
In volunteers with moderate renal impairment (eGFR 30 to. 59 mL/min/1.73 m2), Cmax and AUC were increased by 23% and 66%, respectively. In patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2), mean Cmax and AUC values were 92% and 118% higher compared to healthy subjects with normal renal function.
