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Documents 1-25 out of 35 found
  Current Search:  elspar: 57, asparaginase: 254  

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THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, DALMANE to FURADANTIN
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS DALMANE to FURADANTIN Trade Name Generic DALMANE *Flurazepam DANOCRINE Danazol DANTRIUM Dantrolene DARAPRIM Pyrimethamine DARBID Isopropamide DARVON *Propoxyphene DAYPRO Oxaprozin DDAVP Desmopressin DECADRON Dexamethasone DECLOMYCIN Demeclocycline DELALUTIN Hydroxyprogesterone DELATESTRYL...
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THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Abciximab to Butorphanol
Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Abciximab to Butorphanol Generic Trade Name Abciximab REOPRO Acarbose PRECOSE Acebutolol SECTRAL Acetaminophen TYLENOL Acetazolamide DIAMOX Acetohexamide DYMELOR Acetohydroxamic acid LITHOSTAT Acetophenazine TINDAL Acetylcysteine MUCOMYST ACTH See Corticotropin Acyclovir ZOVIRAX Adenosine ADENOCARD...
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Therapeutic Biological Approvals
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Therapeutic Biological Approvals - Tradename/ Proper Name Indication for Use STN Manufacturer/ License No
Box 3026 Malvern, PA 19355 License 1294 7/12/2002 Elspar Asparaginase Revised Package Insert: Add Geriatric Use subsection in the Precautions section 101063 / 5012 Merck...
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THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, DALMANE to FURADANTIN
Trade Names of Some Commonly Used Drugs TRADE AND GENERIC NAMES OF COMMONLY USED DRUGS DALMANE to FURADANTIN Trade Name Generic DALMANE *Flurazepam DANOCRINE Danazol DANTRIUM Dantrolene DARAPRIM Pyrimethamine DARBID Isopropamide DARVON *Propoxyphene DAYPRO Oxaprozin DDAVP Desmopressin DECADRON Dexamethasone DECLOMYCIN Demeclocycline DELALUTIN Hydroxyprogesterone DELATESTRYL...
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THE MERCK MANUAL OF GERIATRICS, App. III, Trade Names of Some Commonly Used Drugs, Abciximab to Butorphanol
Trade Names of Some Commonly Used Drugs GENERIC AND TRADE NAMES OF COMMONLY USED DRUGS Abciximab to Butorphanol Generic Trade Name Abciximab REOPRO Acarbose PRECOSE Acebutolol SECTRAL Acetaminophen TYLENOL Acetazolamide DIAMOX Acetohexamide DYMELOR Acetohydroxamic acid LITHOSTAT Acetophenazine TINDAL Acetylcysteine MUCOMYST ACTH See Corticotropin Acyclovir ZOVIRAX Adenosine ADENO...
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Asparaginase - Product Approval Information - Licensing Action
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Asparaginase Product Approval Information - Licensing Action Proper name: Asparaginase Tradename: Elspar Manufacturer: Merck and Company, Inc, West Point, PA, License #0002 Revised Package Insert: Add a Geriatric Use subsection in the Precautions section of the package...
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Prescription Drug User Fee Act - User Fee Billable Therapeutic Products: Approved Under Section 351 of the PHS Act
u/vial MedImmune, Inc License 1252 Synagis Palivizumab 103770/0 6/19/1998 50 mg/vial 100 mg/vial Merck & Co., Inc License 0002 Elspar Asparaginase 101063/0 1/10/1978 10,000 IU/vial Novartis Pharmaceuticals Corp License 1244 Simulect Basiliximab 103764/0 5/12/1998 10 mg/vial 20 mg/vial OMJ Pharmaceuticals, Inc License 1196 Regranex Becaplermin 103691/0 12/16/1997 100 mcg...
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Label - Asparaginase (Elspar), Merck and Company, Inc.
DESCRIPTION ELSPAR" (Asparaginase) contains the enzyme L- asparagine amidohydrolase, type EC- 2, derived from Escberichia co/ i
ELSPAR@ (Asparaginase) 7407114 Desensitization: Desensitization should be performed before administering the first dose of ELSPAR on initiation of therapy in positive reactors, and on retreatment of any patient in whom such...

author: CBER,
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Label - Asparaginase (Elspar), Merck and Company, Inc. page 8


author: CBER,
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Label - Asparaginase (Elspar), Merck and Company, Inc. page 7


author: CBER,
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Label - Asparaginase (Elspar), Merck and Company, Inc. page 6


author: CBER,
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Label - Asparaginase (Elspar), Merck and Company, Inc. page 5


author: CBER,
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Label - Asparaginase (Elspar), Merck and Company, Inc. page 4


author: CBER,
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Label - Asparaginase (Elspar), Merck and Company, Inc. page 3


author: CBER,
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Label - Asparaginase (Elspar), Merck and Company, Inc. page 2


author: CBER,
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Label - Asparaginase (Elspar), Merck and Company, Inc. page 1


author: CBER,
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Approval Letter - Asparginase (Elspar), Merck and Company, Inc.
DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 1401 Rockville Pike Our STN: BL 101063/ 5012 Rockville MD 20852- I 448 Taryn Rogalski- Salter, Ph
Rogalski- Salter: Your request to supplement your biologics license application for Asparaginase (ELSPAR@) to add a Geriatric Use subsection in the Precautions section of the package insert has been...

author: CBER
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Approval Letter - Asparginase (Elspar), Merck and Company, Inc. page 2


author: CBER
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Approval Letter - Asparginase (Elspar), Merck and Company, Inc. page 1


author: CBER
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http://www.merck.com/product/usa/pi_circulars/e/elspar/elspar_pi.pdf
9463116 ELSPAR ® (ASPARAGINASE) WARNINGS It is recommended that asparaginase be administered to patients only in a hospital setting under the supervision of a physician who is qualified by training and experience to administer cancer chemotherapeutic agents, because of the possibility of severe reactions, including anaphylaxis and sudden death
Cerebrospinal fluid levels were...


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