Baxter s Products & Services Directory page 14
author: Center for One Baxter
subject: For questions about our Products and Services
duplicates:http://www.baxter.com/customers/products_svcs/2003_products_and_services_directory.pdf
Baxter s Products & Services Directory page 13
author: Center for One Baxter
subject: For questions about our Products and Services
duplicates:http://www.baxter.com/customers/products_svcs/2003_products_and_services_directory.pdf
Baxter s Products & Services Directory Tablets MESNEX* (MESNA) Product Information: Bristol Myers- Squibb Medical Services 800- 426- 7644 ALFENTANIL HYDROCHLORIDE INJECTION ATIVAN (LORAZEPAM) INJECTION AMIODARONE HYDROCHLORIDE INJECTION ATRACURIUM BESYLATE INJECTION ATROPINE SULFATE INJECTION, USP BUMETANIDE INJECTION BUTORPHANOL TARTRATE INJECTION, USP CISplatin INJECTION DILTIAZEM HCI INJECTION DOBUTAMINE INJECTION, USP...
author: Center for One Baxter
subject: For questions about our Products and Services
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
http://www.fda.gov/cder/orange/appendix_a.txt 4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ULTANE, SEVOFLURANE ULTIVA,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt IN MARYLAND HEIGHTS, MISSOURI." 9925 27-Oct-92 SICOR-SOCIETA ITALIANA CORTICOSTEROIDI "VECURONIUM BROMIDE AS MFG
Prescription and Over-the-Counter Drug Product List: 8/2003 4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >D> AB2 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >D> TRANSDERM-NITRO >D> AB2 + NOVARTIS 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >A> @ 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >D> AB2 + 0.2MG/HR N20144 002 FEB 27, 1996 AUG DISC >A> @ 0.2MG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 5/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, APAP, AND CAFFEINE -A- AB AXIOM PHARM 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN -D- AB HALSEY 325MG;50MG;40MG N89536 001 FEB 16, 1988 MAY CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -A- AA ABLE 500MG;7.5MG...
author: AUTHOR
ANDAs Approvals - June 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals June 2000 1VECURONIUM BROMIDE FOR BEDFORD LABORATORIES 6/13/00 INJECTION 10 MG/VIAL 20 MG/VIAL 5
author: USERNAME
First-Time Generics - September 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - September 2001 - Approval Date Drug Name Brand Name ANDA Number Applicant 9/11/01 VECURONIUM BROMIDE FOR INJECTION 4 MG/AMPUL NORCURON FOR INJECTION 75-558 ABBOTT LABORATORIES 9/13/01 LORATADINE TABLETS 10 MG CLARITIN TABLETS 75-209 GENEVA...
author: USERNAME
ANDA Approvals September 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - September 2001 - - ANDA Number-- Drug Name Applicant Approval Date 1 65-026 TOBRAMYCIN OPHTHALMIC SOLUTION 0.3% ALTANA INCVECURONIUM BROMIDE FOR INJECTION 4 MG/AMPUL ABBOTT LABORATORIES 9/11/01 3 75-209 LORATADINE TABLETS 10 MG GENEVA...
author: USERNAME
FDA Drug Approvals List September 2001 - Drug Approvals for September 2001 Definitions and Notes Original New Drug Applications Original Application #: 021279 Approval Date: 25-SEP-01 Trade Name: FORADIL Chemical Type: 3 Therapeutic Potential: S Dosage Form: POWDER, FOR INHALATION Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): FORMOTEROL FUMARATE OTC/RX Status: RX Indication(s): For the long-term, twice...
Prescription and OTC Drug Product List 9/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- ENDO PHARMS 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -D- 400MG;7.5MG N40288 002 NOV 27, 1998 SEP CTEC -D- 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;5MG N40288 001 NOV 27, 1998 SEP CTEC -A- + 400MG;10MG N40288 003 NOV 27, 1998 SEP CTEC -A- + 400MG;7.5MG...
Microsoft Word - 75558.ap.doc ANDA 75- 558 September 11, 2001 Abbott Laboratories Hospital Products Division Attention: Jean Kirkeleit Davis 200 Abbott Park RdVecuronium ...
author: staufferp
Microsoft Word - 75558.ap.doc page 1
author: staufferp
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 OO units Pentagastrin 0.006 mg Pentamidine Isethionate 4.00 mg Pentobarbital Sodium Injection 6.00 mg Pentazocine Lactate Injection 0.86 mg Perphenazine 0.14 mg Phenobarbital Sodium Injection 20.00 mg Phenolsulfonphthalein 0.09 mg Phentolamine Mesylate 0.86 mg Pentylenetetrazol 7.14 mg Phenylephrine HCI 0.20 mg Phenytoin Sodium Injection 20.00 mg Physostigmine Salicylate 0.06 mg...
author: FDA / CBER
subject: December 1987 Guideline
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 page 9
author: FDA / CBER
subject: December 1987 Guideline
Prescription and OTC Drug Product List 8/1999 RTU IN PLASTIC CONTAINER - DLT - MAR 19, 1999 - ADD - AP + BAXTER HLTHCARE 500MG/100ML N18657 001 - DLT - AP + SCS 500MG/100ML N18657 001 LORACARBEF MINOCYCLINE HYDROCHLORIDE CAPSULE; ORAL LORABID CAPSULE; ORAL - ADD - KING PHARMS 200MG N50668 001 - DLT - MINOCYCLINE HCL - ADD - DEC 31, 1991 - DLT - AB WARNER CHILCOTT EQ 50MG BASE N63066 001 - ADD - + 400MG N50668 002 - DLT - AUG 14,...
Prescription and OTC Drug Product List 6/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 6: June 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETOHEXAMIDE BLEOMYCIN SULFATE TABLET; ORAL INJECTABLE; INJECTION ACETOHEXAMIDE BLEOMYCIN - DLT - AB BARR 500MG N70870 001 - ADD - AP GENSIA SICOR PHARMS EQ 15 UNITS BASE/VIAL N65033 001 - DLT - FEB...
FDA Drug Approvals List June 2000 Active Ingredient(s): MIDAZOLAM HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Application # 075448 Approval Date: 19-JUN-00 Trade Name: ISOSORBIDE MONONITRATE Dosage Form: TABLET, EXTENDED RELEASE Applicant: ZENITH GOLDLINE PHARMACEUTICALS Active Ingredient(s): ISOSORBIDE MONONITRATE OTC/RX Status: RX Original Abbreviated Application # 075549 Approval Date: 13-JUN-00 Trade...
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...
http://www.fda.gov/cder/foi/appletter/2000/75549ltr.pdf ANDA 75- 549 June 13, 2000 Bedford Laboratories Attention: Shahid Ahmed 270 Northfield Road Bedford, OH 44146 Dear Sir: This is in reference to your abbreviated new drug application dated December 30, 1998, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act (Act), for Vecuronium Bromide for Injection, 10 mg and 20 mg per vial
http://www.fda.gov/cder/foi/appletter/2000/75549ltr.pdf page 1
FDA Drug Approvals List October 1999 Application #: 020156 Efficacy Supplement#: 022 Type: SE2 to Original New Drug Application Approval Date: 28-OCT-99 Trade Name: VIDEX Dosage Form: POWDER, FOR RECONSTITUTION Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): DIDANOSINE OTC/RX Status: RX Efficacy Claim:Provides for a new strength as well as allowing a change in dosing interval...
http://www.fda.gov/cder/foi/appletter/1999/75164ltr.pdf ANDA 75- 164 October 21, 1999 Abbott Laboratories Attention: Jill Sackett 200 Abbott Park Road, D- 389 AP 30 Abbott Park, IL 60064- 3537 Dear Madam: This is in reference to your abbreviated new drug application dated June 30, 1997, submitted pursuant to Section 505( j) of the Federal Food, Drug, and Cosmetic Act, for Vecuronium Bromide for Injection, 10 mg/ vial and 20 mg...
