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Orexigen Therapeutics, Inc. (Contrave) Untitled Letter 5/18/2017
… Pines Ct., Ste. 200 La Jolla, CA 92037 RE: NDA 200063 CONTRAVE (naltrexone HCl and bupropion HCl) Extended-Release … ad) entitled “BRAIN BOR WOMAN’S DAY: 60” (CON-0303) for CONTRAVE (naltrexone HCl and bupropion HCl) Extended-Release Tablets (Contrave) submitted by Orexigen Therapeutics, Inc. (Orexigen) …
La FDA actúa en contra de cuatro fabricantes de tabaco por la venta ilegal de cigarrillos de sabores identificados como puros o minipuros
Contrave Warning Letter 2020
… Park Place, Suite 201 Morristown, NJ 07960 RE: NDA 200063 CONTRAVE (naltrexone hydrochloride and bupropion … link on the internet search engine, Google.com1 for CONTRAVE (naltrexone hydrochloride and bupropion … hydrochloride) extended-release tablets, for oral use (Contrave) manufactured by Nalpropion Pharmaceuticals LLC …
N200063 Contrave Prearspns 5-10-23
… this study on time. (1) After Nalpropion’s acquisition of Contrave, a contract research organization (CRO) selection … Date / /202 Submission Size Approx. 2 MB ( … N200063 Contrave Prearspns 5-10-23 …
N200063 Contrave Preancltr 4-12-23
… of the Federal Food, Drug, and Cosmetic Act (the Act) for Contrave (naltrexone hydrochloride and bupropion … PM Signature Page 1 of 1 Reference ID: 5156970 ( … N200063 Contrave Preancltr 4-12-23 …
Contrave Promo Material 2020
… … Contrave Promo Material 2020 …
N200063-000 Contrave NC ltr (4-4-17)
… of the Federal Food, Drug, and Cosmetic Act (the Act) for Contrave (naltrexone hydrochloride/bupropion hydrochloride) … GUETTIER 04/04/2017 Reference ID: 4079767 ( … N200063-000 Contrave NC ltr (4-4-17) …
N200063-000 Contrave PREA Response (5-9-17)
… … N200063-000 Contrave PREA Response (5-9-17) …
Currax Pharmaceuticals LLC - 610942 - 09/22/2020
… RE: NDA 200063 CONTRAVE (naltrexone hydrochloride and bupropion … link on the internet search engine, Google.com 1 for CONTRAVE (naltrexone hydrochloride and bupropion … hydrochloride) extended-release tablets, for oral use (Contrave) manufactured by Nalpropion Pharmaceuticals LLC …
Nalpropion Pharmaceuticals LLC - 09/22/2020
… link on the internet search engine, Google.com 1 for CONTRAVE (naltrexone hydrochloride and bupropion … hydrochloride) extended-release tablets, for oral use (Contrave) manufactured by Nalpropion Pharmaceuticals LLC … also received a complaint regarding a sponsored link for Contrave. The sponsored link reviewed by OPDP makes false or …
October - December 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
… hydrobromide and bupropion hydrochloride) Contrave (naltrexone hydrochloride and bupropion … hydrobromide and bupropion hydrochloride) Contrave (naltrexone hydrochloride and bupropion … The “Postmarketing Experience” section of the labeling for Contrave was updated in November 2023 to include Brugada …
La FDA emite carta de advertencia a médico por comercializar ilegalmente un dispositivo no sancionado haciendo afirmaciones de que prevenía y trataba el endurecimiento del tejido cicatricial alrededor de los implantes de seno
October - December 2016 Report | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
… Additional Information (as of October 25, 2023) Contrave (naltrexone HCl and bupropion HCl) extended-release … was updated in May 2017 to include loss of consciousness. Contrave labeling Coumadin (warfarin sodium) tablets, for …
La FDA actúa contra 14 empresas por vender tratamientos ilegales contra el cáncer
La FDA advierte a más empresas que dejen de engañar a los niños con líquidos electrónicos que asemejan alimentos inocuos para los niños, como parte del Plan de Prevención del Tabaquismo Juvenil
La FDA pone sobre aviso a las empresas homeopáticas por poner a los pacientes en riesgo por violaciones considerables a las normas de calidad de manufactura
La FDA y la FTC actúan contra las empresas que engañan a los niños con ‘líquidos electrónicos’ que semejan cartones de jugo, dulces y galletas infantiles
Declaración del Dr. Scott Gottlieb, comisionado de la FDA, sobre las nuevas medidas tomadas por la dependencia para mantener a los consumidores a salvo de los efectos nocivos de la exposición al sol, y garantizar la seguridad y los beneficios de largo plazo de los protectores solares
FD&C Act Chapter IV: Food
October - December 2016 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
… Information Additional Information (as of March 31, 2017) Contrave (naltrexone HCl and bupropion HCl) extended-release …
Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
… tablets 4/19/23 5/10/23 Nalpropion Pharmaceuticals LLC Contrave (naltrexone hydrochloride/bupropion hydrochloride) … tablets 10/15/21 No Response Orexigen Therapeutics, Inc. Contrave (naltrexone hydrochloride/bupropion hydrochloride) …
Indian Cancer Drug Manufacturer to Pay $50 Million for Concealing and Destroying Records in Advance of FDA Inspection
Indian Cancer Drug Manufacturer Agrees to Plead Guilty and Pay $50 Million for Concealing and Destroying Records in Advance of FDA Inspection