http://www.fda.gov/cder/orange/appendix_a.txt ACTHAR GEL, CORTICOTROPIN H.R.-50, HYDROCHLOROTHIAZIDE HABITROL, NICOTINE (OTC) HALCION, TRIAZOLAM HALDOL SOLUTAB, HALOPERIDOL HALDOL, HALOPERIDOL HALDOL, HALOPERIDOL DECANOATE HALDOL, HALOPERIDOL LACTATE HALDRONE, PARAMETHASONE ACETATE HALFAN, HALOFANTRINE HYDROCHLORIDE HALOG, HALCINONIDE HALOG-E, HALCINONIDE HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE HALOPERIDOL INTENSOL,...
OGD, First Time Approvals - May 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - May 2002 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1- IDARUBICIN HYDROCHLORIDE FOR INJECTION, USP 5 MG, 10 MG, AND 20 MG SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INCIDARUBICIN ...
author: OGD
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
February Drug Approvals Drug Approvals for February 1997 Definitions and Notes February 1997 Original New Drug Applications Original Application #: 020723 Approval Date: 27-FEB-97 Trade Name: ALDARA Chemical Type: 1 Therapeutic Potential: S Dosage Form: CREAM Applicant: 3M PHARMACEUTICALS INC Active Ingredient(s): IMIQUIMOD OTC/RX Status: RX Indication(s): Treatment of external genital and perianal warts...
FDA Drug Approvals List August 1999 Approvable Original New Drug Applications Original Application #: 021037 Approvable Date: 26-AUG-99 Trade Name: MAGNEVIST Dosage Form: INJECTABLE Applicant: BERLEX LABORATORIES INC Active Ingredient(s): GADOPENTETATE DIMEGLUMINE OTC/RX Status: RX Original Application #: 020989 Approvable Date: 27-AUG-99 Trade Name: EVOXAC Dosage Form: CAPSULE Applicant: SNOWBRAND PHARMACEUTICALS INC...
HM6681 522..540 522 q 2001 The UK Myeloma Forum Guideline DIAGNOSIS AND MANAGEMENT OF MULTIPLE MYELOMA METHODS These guidelines have been compiled by the Guidelines Working Group of the UK Myeloma Forum on behalf of the British Committee for Standards in Haematology (BCSH).
duplicates:http://www.int-med.uiowa.edu/Intranet/Residents/xToDelete/GMedCurricOld/Jan-Jun%2004/MultipleMyeloma/522.pdf
http://www.fda.gov/cder/drug/cancer_endpoints/endpointsArticle.pdf End Points for Approval of Oncology Drug Marketing Applications January 1, 1990 to November 1, 2002 Drug (year, application type) Indication Approval Type End Points Supporting Approval Trial Design Altretamine (1990, N) Refractory ovarian cancer Regular RR SAT Altretinoin gel (1999, N) Kaposi's sarcoma, cutaneous lesions Regular RR, cosmesis RCT Amifostine (1995, N) To decrease...
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RLD_LABELING_ APPROVED_AUG_1999 Product Name Drug Name NDA No Supp.No Firm Date LARIAM Mefloquine HCl Tablets 19-591 S-012 Roche 02-Aug-1999 PROSCAR Finasteride Tablets 20-180 S-018 Merck 02-Aug-1999 CEFOTAN Cefatetan Disodium 50-588 S-026 Zeneca 05-Aug-1999 MARINOL Dronabinol Capsules 18-651 S-011 Unimed 05-Aug-1999 ZOCOR Simvastatin Tablets 19-766 S-032 Merck 05-Aug-1999 GLUCOTROL Glipizide Tablets 17-783 S-015...
http://www.fda.gov/cder/foi/label/2003/50734slr005_idamycin_lbl.pdf ( See DOSAGE AND ADMINISTRATION.) DESCRIPTION IDAMYCIN PFS Injection contains idarubicin hydrochloride and is a sterile, semi- synthetic, preservative- free solution ( PFS) antineoplastic anthracycline for intravenous useidarubicin and idarubicinol bound to human plasma proteins averaged 97% and 94%, respectively, at concentrations...
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http://www.fda.gov/cder/foi/appletter/2003/50734slr005ltr.pdf DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville, MD 20857 NDA 50- 734/ S- 005 Pharmacia and Upjohn Corporation 1425 Route 206 South, Mailstop 024 Bedminster, NJ 07921 Attention: Lynne Fahey McGrath, MPH, Ph
author: SPILLMAND
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author: SPILLMAND
C:\data\My Documents\PENDING\Nimby\BAtkins\N50-661-slr007-ap-ltr.d\ oc DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 50- 661/ S- 007 Pharmacia & Upjohn Company Unit 0633- 298- 113 7000 Portage Road Kalamazoo, MI 49001 Attention: Gregory A
author: Dianne Spillman
C:\data\My Documents\PENDING\Nimby\BAtkins\N50-661-slr007-ap-ltr.d\ oc page 1
author: Dianne Spillman
http://www.fda.gov/cder/foi/label/2002/50467s64s67,50629s10s13lbl.pdf INDICATIONS AND USAGE: ADRIAMYCIN PFS and ADRIAMYCIN RDF have been used successfully to produce regression in disseminated neoplastic conditions such as acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms' tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric...
http://www.fda.gov/cder/foi/label/2002/50467s64s67,50629s10s13lbl.pdf page 2
http://www.cancercare.on.ca/formulary/pdfdrugs/EPIRUBIC.pdf Epirubicin CCO Formulary Revised March 2000 A DRUG NAME: EPIRUBICIN SYNONYM( S): 4'- epi- doxorubicin, NSC- 256942, IMI28, epi DX COMMON TRADE NAME( S): Pharmorubicin® RDF, Pharmorubicin® PFS (Pharmacia & Upjohn) B MECHANISM OF ACTION AND PHARMACOKINETICS Epirubicin is a stereoisomer of doxorubicin ...
http://www.fda.gov/cder/ogd/rld/50734s4.pdf Steindler: Please refer to your supplemental new drug application dated January 21, 1999, received January 22, 1999, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Idamycin PFS (idarubicin hydrochloride injection)
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