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February 24, 2021

FDA Drug Safety Communication: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death

[05-19-2016] The U.S. Food and Drug Administration (FDA) is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and […]
February 24, 2021

FDA advierte acerca del riesgo de sangrado grave en antiácidos de venta libre que contienen aspirina

La Administración de Alimentos y Medicamentos de EE. UU. (FDA) advierte a los consumidores acerca del riesgo de sangrado grave al utilizar antiácidos de venta libre, […]
February 24, 2021

Untitled Letters 2018

These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion’s untitled letters.  The agency may have redacted […]
February 24, 2021

Untitled Letters 2019

These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion’s untitled letters.  The agency may have redacted […]
February 24, 2021

Untitled Letters 2020

These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion’s untitled letters.  The agency may have redacted […]
February 24, 2021

Untitled Letters 2021

These letters are supplied by the CDER Freedom of Information Office and only covers Office of Prescription Drug Promotion’s untitled letters.  The agency may have redacted […]
February 23, 2021

Coronavirus (COVID-19) Update: February 23, 2021

For Immediate Release: February 23, 2021 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
February 23, 2021

2020 First Generic Drug Approvals

  ANDA Number Generic Name ANDA Applicant Brand Name ANDA Approval Date ANDA Indication+ 72 208086 Glucagon for Injection USP, 1 mg/vial packaged in an emergency […]
February 23, 2021

Absara Cosmetics S.A.P.I DE C.V. – 612455 – 02/18/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Daniel Chamlati Recipient Title Chief Executive Officer Absara Cosmetics S.A.P.I DE C.V. Autopista Mexico – Toluca […]
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