DRAFT Response to NDA Draft Socio-Economic Policy Consultation 2006/07 Reference: NDA/SEP/RESP/1106 F Duffy & D Davies - November 2006 1. ... more>>
Kelly Jackson NDA Herdus House Westlakes Science and Technology Park Cumbria CA24 3HU 19 January 2007 Dear Ms Jackson, NDA SOCIO-ECONOMIC POLICY CO ... more>>
NDA 20743/S002 NORITATE (metronidazole cream) Cream, 1% FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE) DESCRIPTION NORITATE (metronidazole cream) C ... more>>
NDA 50-649/S-020 Page 19 PATIENT INFORMATION MINOCIN® [my-no-sin] (minocycline hydrochloride) Pellet-Filled Capsules 50 and 100 mg Read the Patient In ... more>>
NDA 18-677/S-011 Page 3 CESAMET™ (nabilone) Capsules For Oral Administration DESCRIPTION Cesamet™ (nabilone) is a synthetic cannabinoid for oral adm ... more>>
NDA 20-998/S-017 Page 3 CELEBREX celecoxib capsules DESCRIPTION CELEBREX (celecoxib) is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluorome ... more>>
NDA 20-985/S-004 Page 3 Carac Cream, 0.5% (fluorouracil cream) FOR TOPICAL DERMATOLOGICAL USE ONLY (NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE) ... more>>
NDA 16-733/S-049 Page 3 DRAFT PACKAGE INSERT Y36-002-475 Package Insert PIC™ (Plastic Irrigation Container) ________________________________________ ... more>>
NDA 22-010 Page 3 Septocaine® with epinephrine 1:100,000 Septocaine® with epinephrine 1:200,000 (articaine hydrochloride 4% (40 mg/mL) with epinephrin ... more>>
NDA 20-723/S-018 Page 3 ALDARA [al dar' a] (imiquimod) Cream, 5% For Dermatologic Use Only Not for Ophthalmic Use DESCRIPTION Aldara is the brand n ... more>>
NDA 19-452/S-016/S-019 & S-020 Page 4 Derma-Smoothe/FS fluocinolone acetonide Topical Oil, 0.01% (Body Oil) For Topical Use OnlyNot for Not for ... more>>
NDA 21-551/S-006 Page 5 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use HalfLytely and Bisacod ... more>>
NDA 20-757/S-039 Page 3 AVAPRO (irbesartan) Tablets USE IN PREGNANCY When used in pregnancy during the second and third trimesters, drugs that act dir ... more>>
NDA 16-295/S-037 Page 3 Rx only HYDREA (hydroxyurea capsules, USP) DESCRIPTION HYDREA (hydroxyurea capsules, USP) is an antineoplastic agent, avail ... more>>
AROMASIN® (exemestane tablets) NDA 20-753/S-006 October 4, 2005 S-006 Approved Labeling EBC Indication AROMASIN® exemestane tablets DESCRIPTION ARO ... more>>