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Center of the administration of the food and the drug of the United States for the evaluation and the investigation of the drugPopup of hun

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Content In This Page
  • New Approvals Of the Drug Of the Prescription
  • Information Of the Drug Of the Prescription
  • Pioneer Of the Information Of the Drug
  • Important pages Of the Information Of the Drug
  • Information Of the Drug Of the Consumer
  • Information Of the Drug Of Sobre-$$$-Contador
  • Security Of the Drug and Indirect effect
  • State of preparation of the drug and answer of Bioterrorism
  • Clinical information Of the Tests
  • Admonishing alarms Of the Public Health and Letters
  • Information and publications
  • Special Projects And Programs

New Approvals Of the Drug Of the Prescription

  • Drugs@FDA
  • New and generic approvals of the drug - this is an alphabetical listing of all the prescription and drugs to over-the-counter approved during 1998 to 2003.   It is updated on a daily base and it contains connections to the labels, the letters of the approval, and to the revisions.
  • The index to theDroga-Especi'fica information   provides connections to the consumer, the patient, and the professional leaves of Healthcare, and more.
  • List Of the Approvals Of the Drug of the FDA .   This is a chronological listing reverso of all approved drugs September of 1996 to the one of August 12 of 2002.
  • The new drugs approved for the indications of the cancer. This is a present listing of new drugs of the cancer.  It is prepared by Office of FDA of special editions of the health.

Information Of the Drug Of the Prescription

  • Approved drug products with the therapeutic book of Evaluations/Orange equivalence . The book of the orange enumerates all approved drugs FDA of the prescription, including new and generic drugs.  The orange page of the book includes a investigateable orange book, as well as a version of the text, supplements, and files of data downloadable.  It is updated on a monthly base.
  • Biological Therapeutic Products
  • Drugs that will be continued
  • National directory Of the Code Of the Drug (Ndc) (Put to day 4/6/2005).  The national system of the code of the drug (NDC) was established originally like essential part of a program of the reimbursement of the drug of towards be-of-hospital under Insurance of disease. The NDC serves like universal identifier of the product for human drugs. The present edition of the national directory of the code of the drug is limited drugs of the prescription and some selected products of OTC.
  • National directory Of the Code Of the Drug. Data base Investigateable (4/6/2005) 
  • Inactive data base Of the Ingredient.  The data base provides the information in the present inactive FDA-approved drug product ingredients. This information can be used by the industry like drug product aid that becomes. 
  • The index to theDroga-Especi'fica information   provides connections to the consumer, the patient, and the professional leaves of Healthcare, and more.

Pioneer Of the Information Of the Drug

  • Pioneer Of the Information Of the Drug. He provides connections to the information in specific drugs, the development of the drug, the process of use of the drug, the imports of the drug, and other subjects. (4/22/2004)

Important pages Of the Information Of the Drug

For the information on specific drugs, it please sees the index theDroga-Especi'fica information

  • Analgesias: Safe use of the mitigadores of the pain Sobre-$$$-Contador (analgesias) and reducers of the fever (antipyretics) (1/22/2004)
  • Use of the antidepressant in children, adolescents, and the adults (3/22/2004)
  • Page of the information of Baycol (cerivastatin) (8/8/2001)
  • Information De Cenestin: The Conjugated Estrogens Synthetic Approved (Put to day 3/26/1999)
  • Selective and nonselective antiinflammatory drugs No-non-Steroidal of COX-2 (NSAIDs) (4/7/2005)
  • Opposite drugs of the terrorism (it includes calcium-DTPA and zince-DTPA, cipro, doxycycline, levaquin, blue prusiano, procaína of G of penicillin, and bromide of pyridostigmine)
  • Estrogen and estrogen with the therapies of the progestina for the women of Postmenopausal (1/8/2003, put to day 2/10/2004) 
  • Products De Droga Pancreáticos Exocrine Of the Shortage (4/27/2004)
  • information of "Pantano-Phen" (fenfluramine, phentermine, dexfenfluramine) (put to day 7/23/1999)
  • Antivirus drugs Of the Influenza (Influenza)
  • Drugs Antiinflamatorias No-Non-Steroidal (NSAIDs) (4/7/2005)
  • Hurt to the mitigadores (analgesias) and reducers of the fever (antipyretics)
  • Page of the information of Phenylpropanolamine (PPA) (11/2000, put to day 3/17/2003)
  • Page Of the Information De Plenaxis (11/25/2003)
  • Page Of the Information De Prilosec OTC (6/20/2003) 
  • Page of the information of the tablets of Subutex and Suboxone (10/8/2002)
Information Of the Drug Of the Consumer
  • The index to theDroga-Especi'fica information   provides connections to the consumer, the patient, and the professional leaves of Healthcare, and more.
  • Antimicrobiana page Of the Resistance (1/25/2001)
  • Common medicines of the abuse: Marijuana. Information of the national institute in abuse of the drug.  
  • Education Of The Consumer: What you must know on buying and using drug products
  • Insulin Of the Meat of cow: Questions frequently done on the import of the insulin of the meat of cow for the personal use (12/13/2001).
  • Shortages Of the Drug
  • Generic Drugs: Questions and answers
  • How To obtain Domperidone (5/18/2005)
  • Drugs antivirus and related information ( 12/27/2000) of the influenza.
  • Inhalants of Medir-Dosis (MDIs) (put to day 3/31/2005)

Information Of the Drug Of Sobre-$$$-Contador

  • Page Of the Drug Of Sobre-$$$-Contador.  Information for the consumers and trains on drugs non-prescription. 

Security Of the Drug and Indirect effect

  • The index to theDroga-Especi'fica information   provides connections to the consumer, the patient, and the professional leaves of Healthcare, and more.
  • Accutane (isotretinoin): A letter to the consumers and the suppliers of the medical care. Optional Format: Pdf.   The Dr Janet Woodcock, Director of CDER (1/9/2001)
  • Adverse events That disclose the System (Put to day 8/7/2002)
  • Electronic submissions of AERS (Put to day 4/12/2001)
  • Paper Of the Edition De Clozapine (2/1/2001)
  • Medical bulletin of the FDA - important information for the professionals of health of the administration of the food and the drug of the United States.
  • Declaration of the FDA on the results of the initiative of the health of the women (8/13/2002)
  • Changes of labeled related to the security of the drug .  The summaries include only those sections relative to the security have been modified that, and therefore do not contain all the needed information to prescribe surely and effective. Between in contact with the manufacturer for the complete filling of labeling/package.
  • Branch De Etiquetado Of the Revision .   This page of the unit of the organization contains updates of labeled recent.  
  • Page Of the Web Of the Errors Of the Medication
  • MedWatch - the Web site for the medical program of spreading of products of the FDA.
  • Vaginal cream of Miconazole and information of the security of the updates of the FDA of the information of the security  of the suppositories 3/5/2001) (for the cream and the vaginal suppositories of Miconazole.  The FDA advises to women who take warfarin from the deluente of the blood of the prescription to consult to their doctor or phamacist for the advice before using vaginal products of miconazole to over-the-counter.  To use products both together could cause to the drain or the contusion.
  • 2/26/2001) patient final summary of security (of articles of action of the administration of the food and the drug (FDA) - doing what counts for the patient security: Federal actions to reduce to medical errors and their impact
  • Adverse reactions Preventable Of the Drug:  A center in interactions of the drug. (Module That learns).  (6/2002)
  • Backgrounder Inhibitors ( 12/3/1997) Of The Protease.  The inhibitors of protease are members of a class of antiretrovirals that are considered generally to be more powerful the therapeutic agents for the VIH to date.  In the order so that these drugs are effective and reduce to the minimum the risk of the resistance, it is important that these drugs are prescribed and taken in agreement with the approved labeled one from products.
  • Disclosing adverse reactions and other problems with products regulated by FDA .  The consumers know to play an important role of the public health disclosing to the food of the United States and administration of the drug cualquieres adverse reactions or other problems with the products that the agency regulates.
  • The security of sodium applies to phosphate layer the oral solution (10/12/2001)
  • Visicol: Backgrounder Science: The grasping was associated to the use of Visicol for Colonoscopy - additional information (6/27/2002)

State of preparation of the drug and answer of Bioterrorism

  • State of preparation of the drug and answer of Bioterrorism

Clinical information Of the Tests

  • Information for the clinical investigators
  • Participation of the groups of Racial/Ethnic in clinical tests and labeled Raza-Relacionado:  A revision of new molecular organizations approved 1995-1999. (12/7/2001)
  • This   source of ClinicalTrials.Gov provides patients, the families and the members of public the easy access to the information on the location of clinical tests, its design and intention, the criteria for the participation, and, in many cases, additional information on the disease and treatment under study.
  • Clinical Enumerar Of the Tests Of the Cancer   (4/6/1999). This is an alphabetical listing of the organizations of the cancer with the extensive information on treatments of the cancer and clinical tests.

Admonishing alarms Of the Public Health and Letters

  • Public health Advisories, 1997 to the present
  • Warnings of the alcohol for the mitigadores and reducers of the fever ( 10/22/1998) of the pain
  • Inhaled oral class that labels for the intranasal corticoesteroide and that contains drug products with respect to the potential for the suppression of the growth in the children   (11/9/1998)
  • Report Of the Application of the FDA .   The report of the application of the FDA is published weekly by the administration of the food and the drug of the United States. It contains the information on the actions taken in the connection with regulating activities of the agency.
  • The FDA publishes alarm on the erroneous use of the consumption products that contain acid hydroxybutyric gamma (GHB), butyrolactone gamma (GBL), and the letter and the poster of butanediol 1,4 (BD).  Optional Format: GIF (fixed 7/22/1999)
  • Answer of the FDA to the letters that ask for the approval of Temozolomide for the treatment of the patients of the adult with glioma bad in the first relapse, of April the 14 of 1999 . (fixed 4/23/1999)
  • The FDA takes the action against disapproved drugs from the firm commercialization .  The press launching discloses the prescription looked for against the commercialization of disapproved drugs: BeneFin, SkinAnswer and MGN-3.  (12/10/1999)
  • Therapeutic equivalence of the generic letter of drugs to the doctors of the health (2/4/1998)
  • Therapeutic equivalence of the generic answer of drugs to board the national association of the pharmacy (2/6/1998)
  • Admonishing letters and warning of the letters of the violation.  The care these and the warning of the letters of the violation, classified per month, are provided by the freedom of CDER of the information bureau.

Information And Publications

  • Guide of CDER to the medium statistic of the time of the approval (1/31/2003) 
  • Main archives Of the Drug (1/10/2006)
    The main archives of the drug (DMFs) are submissions to the FDA that contains the confidential information of the manufacture on drugs, the materials of packed, and the excipientes. This site contains lists of all the DMFs with DMF 19014 (current of DMFs in date of December the 31 of 2005). The lists are quarterly updated. The site also contains the information on the limadura DMFs.
  • Librete of the registry of the drug and the instruction of the system of the listing (4/16/1998).  The act of the listing of the 1972 drug, amending the federal food, drugs, and cosmetic act, became of effective February the 1 of 1973. Its intention is to provide to the commission of the FDA that  a present list of all drugs made, prepared, propagated, compound, or processed by an establishment of the drug registered under the federal food, the drug, and cosmetic act.
  • The evaluation of the written information of the prescription provided in the pharmacies of the community, 2001 (6/18/2002)
  • Special edition of the consumer of the FDA - of the tube of test to the patient .
    This article describes the process of the approval of the drug of a perspective of the consumer.
  • Times of the revision and the approval of the drug of fDA (7/27/2001).

Special Projects And Programs

  • Information of the AIDS . Offer of the federal information approved last on the clinical investigation, tests, and the treatment for the patients and the suppliers of the medical care. (External Site)
  • Analgesia and antiinflammatory information of the drug (7/15/2002)
  • Approvals of the drug of the VIH of Antiretroviral and labeled information of pediátrica (published 1/7/1998, fixed 1/7/1998).   This letter enumerates the name of the drug, the company, the date of the approval of the adult, and the pediátrica date of the approval (if he is appropriate).
  • Botanical equipment Of the Revision (Development De Botanical Producto De Droga) (3/26/2004)
  • Final points Of the Approval Of the Drug Of the Cancer: The FDA projects and the information of the meeting. (11/13/2003)
  • Tools Of the Oncología of the FDA.  The tools of the oncología contain a variety of information related to the cancer and drug the approved therapies of the cancer
  • Pediátrico development Of the Drug
  • Pharmaceutical GMPS: ARiesgo-Basado Approach (2/20/2003)
  • Commissions Of The Study De Postmarketing (5/2003)
  • Analytical web page of process of the technologies (LIGHT TAP) (2/5/2003)


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FDA/Center for the evaluation and the investigation of the drug
Updated Happened: Of January the 10 of 2006
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