Accessdata.fda.gov

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National Drug Code Directory

(9 days ago) National Drug Code Directory. The National Drug Code (NDC) Directory is updated daily. Current through: 11/29/2022. NDC Application Programming Interface (API) (Firefox and Chrome …

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Orange Book: Approved Drug Products with Therapeutic …

(8 days ago) The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

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Search Orphan Drug Designations and Approvals

(5 days ago) Search Orphan Drug Designations and Approvals. This page searches the Orphan Drug Product designation database. Searches may be run by entering the product name, orphan …

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Search Orphan Drug Designations and Approvals

(9 days ago) FDA Home. Developing Products for Rare Diseases & Conditions. This page searches the Orphan Drug Product designation database. Searches may be run by entering the product …

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Reference ID: 3093489

(5 days ago) Effects of Sitagliptin on Other Drugs . In clinical studies, as described below, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, …

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HIGHLIGHTS OF PRESCRIBING INFORMATION

(5 days ago) anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1 .1) • Increase survival in patients acutely exposed to myelosuppressive doses of radiation …

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CENTER FOR DRUG EVALUATION AND RESEARCH

(9 days ago) • Relapsed or refractory Hodgkin's lymphoma in combination with other approved drugs • Relapsed or refractory Non-Hodgkin's lymphomas in combination with other approved drugs …

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U.S. Food & Drug Administration www.fda

(4 days ago) REPORTING REQUIREMENTS We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81). If you have any questions, call Grecia C. …

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I/ lfflll U.S. FOOD DRUG ~,--::Jl'-- ADMINISTRATION

(4 days ago) Prescription Drugs. 3 . As required under 21 CFR 601.12(f)(4), you must submit final promotional materials, and the Prescribing Information, at the time of initial dissemination or publication, …

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NDA 210850 NDA APPROVAL

(4 days ago) NDA 210850 Page 2 U.S. Food and Drug Administration Silver Spring, MD 20993 www.fda.gov FDA.gov.1 Content of labeling must be identical to the enclosed labeling (text for the …

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SPRYCEL (dasatinib) tablets label

(5 days ago) 7.3 Drugs That May Have Their Plasma Concentration . 2 DOSAGE AND ADMINISTRATION . Altered By Dasatinib . 2.1 Dose Modification . 8 USE IN SPECIFIC POPULATIONS . 2.2 Dose …

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Reference ID: 2894777

(5 days ago) 7.2 Drugs that Interfere with Hemostasis (e.g., NSAIDs, aspirin, and warfarin) 7.3 Potential for Other Drugs to Affect Vilazodone 7.4 Potential for Vilazodone to Affect Other Drugs. 7.5 …

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Depakote (divalproex sodium) Tablets

(5 days ago) • Suicidal behavior or ideation; Antiepileptic drugs, including Depakote, increase the risk of suicidal thoughts or behavior (5.6) • Thrombocytopenia; monitor platelet counts and …

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CENTER FOR DRUG EVALUATION AND RESEARCH

(1 days ago) drugs, including Entocort EC (NDA 021324, approved on 10/2/01). • DCN consulted DPMH on 7/29/21, to provide input for appropriate labeling of the . Pregnancy. and . Lactation. …

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