Bioniche February 12, 2008 Bioniche Reports Fiscal 2008 Second Quarter February 8, 2008 Bioniche Receives $5 Million Capital Financing Support to Scale-up E.
ProductCatalog Pr o d u c t s 2 0 0 3/ 2004 PHARMA GROUP LIMITED Bioniche Life Sciences Inc.
author: Kathy Vandermey
duplicates:http://www.bioniche.com/pdf/ProductCatalog.pdf
ProductCatalog page 7
author: Kathy Vandermey
duplicates:http://www.bioniche.com/pdf/ProductCatalog.pdf
ProductCatalog page 3
author: Kathy Vandermey
duplicates:http://www.bioniche.com/pdf/ProductCatalog.pdf
IROA - Scientific Study Reference Search Pellets 2-Acetamidofluorene (2-AAF) 2-Acetylaminofluorene (AAF) 2-OHE1 3,3',5-Triiodo-L-Thyronine (T3) 4-Hydroxyandrostene-3,17-dione (4-OHA) 4-Hydroxyandrostenedione 5a-Androstan-3a + 17ss-diol 5a-Dihydrotestosterone (5a-DHT) 5a-Dihydrotestosterone (5a-DHT) 5a-Reductase Inhibitor (4MA) 5-Bromo-2'-Deoxyurdine (BrDU) 5a-Dihydrotestosterone (5a-DHT) 6-n-Propyl-2-Thiouracil (PTU...
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,...
Drug Approvals - K Product Name Company Application # Approval Date Letter Posted Label Posted Review Posted Kaletra (lopinavir) oral solution, 80mg lopinavir/20mg ritonavir
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt LOUIS, MISSOURI" 13133 14-Aug-98 ELAN PHARMA INC "RITALIN QD (METHYLPHENIDATE) ONCE DAILY CAPSULES, MANUFACTURED IN IN GAINSVILLE, GA (PRIMARY) AND ATHLONE, COUNTY WESTMEATH, IRELAND (ALTERNATE)" 13135 14-Aug-98 INSTITUTE DRUG TECHNOLOGY AUSTRALIA LTD "LOXAPINE BASE, MANUFACTURED IN BORONIA VICTORIA, AUSTRALIA" 13141 18-Aug-98 ARZNEIMITTELWERK DRESDEN GMBH "KETAMINE ...
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004 - SOLUTION; ORAL Approved 8/20/2001- KETAMINE HYDROCHLORIDE 100 MG/ML-10ML VIALS - 01P-0156/CP1 BIONICHE PHARMA GROUP - INJECTION Approved 8/20/2001- PROPOXYPHENE NAPSYLATE; 100 mg ACETAMINOPHEN 325 mg - 01P-0186/CP1 ARNALL, GOLDEN & GREGORY - TABLET; ORAL Approved 8/20/2001- ACETAMINOPHEN; 320 MG/10 ML HYDROCODONE BITARTRATE 10 MG/10 ML - 01P-0130/CP2 PHARMACEUTICAL...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004 - INJECTION Approved 4/23/2001- ISOTRETINOIN 30 mg - 02P-0161/CP1 LACHMAN CONSULTANT SERVICES - CAPSULES Approved 8/8/2002- KETAMINE HYDROCHLORIDE 100 MG/ML-10ML VIALS - 01P-0156/CP1 BIONICHE PHARMA GROUP - INJECTION Approved 8/20/2001- KETOPROFEN; 12.5 MG HYDROCODONE BITARTRATE 7.5 MG - 03P-0453/CP1 KING & SPALDING LLP - TABLET Pending - KETOROLAC TROMETHAMINE 30 MG/ML -...
http://www.paddocklabs.com/forms/secundum/volume_9_1.pdf Secundum Artem VOLUME 9 NUMBER 1 Current & Practical Compounding Information for the Pharmacist
http://www.paddocklabs.com/forms/secundum/volume_9_1.pdf page 4
ANDA Approvals December 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - December 2001 - - ANDA Number Drug Name Applicant Approval Date 1 75-427 CROMOLYN SODIUM NASAL SOLUTION, USP (OTC) 5.2 MG DELIVERED/SPRAY, (40 MG/ML), 13 ML & 26 ML METERED SPRAY BOTTLES L
author: USERNAME
1997 Abbreviated New Drug Applications (Generic Drugs) 074946 11/19/1997 3/30/1998 Adriamycin PFS (Doxorubicin Hydrochloride) Injection ,- Adria Laboratories 63165/S3, S5, S6 7/9/1993 8/8/2002 Albuterol Inhalation Aerolsol, 90 mcg/ActuationHydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
FDA Drug Approvals List December 2001 - Drug Approvals for December 2001 Definitions and Notes Original New Drug Applications Original Application #: 021165 Approval Date: 21-DEC-01 Trade Name: CLARINEX Chemical Type: 1 Therapeutic Potential: S Dosage Form: TABLET Applicant: SCHERING PLOUGH CORP Active Ingredient(s): DESLORATADINE OTC/RX Status: RX Indication(s): For the relief of the nasal and non-nasal symptoms of...
FDA Drug Approvals List February 2001 Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
Prescription and OTC Drug Product List 12/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG;5MG N40409...
Prescription and OTC Drug Product List 10/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 325MG;7.5MG N40464 001 OCT 23, 2002 OCT NEWA -A- AA 325MG;10MG N40464 002 OCT 23, 2002 OCT NEWA -A- AA 650MG;10MG N40476 001 OCT 23, 2002 OCT NEWA -A- AA 750MG;7.5MG N40469 001 OCT 25, 2002 OCT NEWA -A- AA MALLINCKRODT 750MG...
Corel Ventura - 19E2.CHP page 1
author: dawns
Guideline on Validation of the Limulus Amebocyte Lysate Test As An End-Product Endotoxin Text for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices Ioxaglate Sodium Iron Dextran Injection Iron Sorbitex Isobucaine HCI and Epinephrine Isoniazid Isoproterenol HCI Injection Isosuifan Sulfate Isoxsupine HCI Injection Kanamycin Sulfate Injection Ketamine HCI Labetalol HCI Leucovorin Calcium Injection Leuprolide Acetate Levallorphan Tartrate Injection Levarterenol Levorphanol Tartrate Injection Levothyroxine Sodium for Injection...
author: FDA / CBER
subject: December 1987 Guideline
http://www.paddocklabs.com/forms/secundum/volume_8_4.pdf Secundum Artem VOLUME 8 NUMBER 4 Current & Practical Compounding Information for the Pharmacist
http://www.paddocklabs.com/forms/secundum/volume_8_4.pdf page 4
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf M e t h a d o n e: Methadone is a synthetic analgesic drug that is originally used in the treatment of narcotic addicts. Among the psychological effects induced by using methadone are analgesia, sedation and respiratory depression. Overdose of methadone may cause coma or even death. It is administered ...
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf page 2 PERFORMANCE CHARACTERISTICS A. Accuracy For each individual drug screen assay, approximately 60 urine samples of specific drugs were obtained form clinical laboratories. The concentration of drug present in the samples was determined by either GC/ MS or commercial kits. Each sample was then ...
FDA Drug Approvals List March 2000 Original Application #: 021124 Approval Date: 17-MAR-00 Trade Name: LAMISIL Chemical Type: 6 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: NOVARTIS PHARMACEUTICALS CORP DBA SANDOZ PHARMACEUTICALS CORP Active Ingredient(s): TERBINAFINE HYDROCHLORIDE OTC/RX Status: RX Indication(s): For the treatment of interdigital-type pedis (athlete’s foot), tinea cruris (jock...
