Drug Approvals - B - ANDA 76-476 2/11/04 2/12/04 - - Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Andrx Pharmaceuticals ANDA 76-267 2/11/04 2/12/04 - - Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Tentatively Approved Andrx Pharmaceuticals ANDA 76-267 2/26/03 - - - Benazepril Hydrochloride Tablets, 5, 10, 20 & 40 mg, Rx Teva Pharmaceuticals ANDA 76-211 2/11/04 2...
http://www.fda.gov/cder/orange/appendix_a.txt 3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE #3, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN W/ CODEINE, ACETAMINOPHEN ACETAMINOPHEN, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC) ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE, ACETAMINOPHEN ACETAMINOPHEN, BUTALBITAL AND CAFFEINE, ACETAMINOPHEN ACETAMINOPHEN,...
Prescription and Over-the-Counter Drug Product List: 7/2003 >A> @ FERRING 5,000 UNITS/VIAL N17055 001 JUL CAHN >A> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >A> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN >D> @ WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUL CAHN >D> @ 10,000 UNITS/VIAL N17055 002 JUL CAHN >D> @ 20,000 UNITS/VIAL N17055 003 JUL CAHN GRANISETRON HYDROCHLORIDE SOLUTION; ORAL KYTRIL >D> @ ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27,...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- + ANDRX PHARMS 500MG;30MG N40441 001...
author: AUTHOR
FDA Drug Approvals List February 2000 - Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
Prescription and OTC Drug Product List 2/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 2: February 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CICLOPIROX TABLET; ORAL CREAM; TOPICAL LORTAB LOPROX - DLT - UCB 325MG;5MG N40099 001 - ADD - + AVENTIS PHARMS 0.77% N18748 001 - DLT - JUN 25, 1997 - ADD -...
Pharmaceutical Research and Manufacturers of America - Alcon Research Complete a new search Drug Name (Proprietary name/Generic name) Indications Addressed Click on indication to see all drugs for that indication Company Click a company to see all drugs for that company Development Status Notes Azopt none / brinzolamide opthalmic solution, 1% Eye Diseases Alcon Research Fort Worth, TX application submitted 2 weeks-6 years - Betaxon ...
Report to the Nation: Drug Review Priority new drug approvals (N=NME) Abacavir/lamivudine/zidovudine (Trizivir) Alosetron (Lotronex) (N) Arsenic trioxide (Trisenox) (N) Atovaquone/proquanil (Malarone) Bexarotene (Targetin) Budesonide (Pulmicort) Didanosine (Videx EC) Gentuzumab ozogamicin (Mylotarg) (N) Levobetaxolol (Betaxon) Levofloxacin (Quixin) Linezolid (Zyvox) (3 NDAs approved, 1 as NME) (N)...
author: OLIVERN
FY 2000 USER FEE PRIORITY APPROVALS FY 2000 USER FEE PRIORITY APPROVALS NDA# - Trade Name (Generic Name) Dosage Form Applicant Date of Approval Class Indication(s) 21-087 Tamiflu (oseltamivir phosphate) Capsules Hoffmann-La Roche 27-Oct-99 1P Tamiflu is indicated as a treatment of influenza A and BBetaxon (...
author: Brenda Harmon
http://www.fda.gov/cder/foi/label/2000/21114lbl.pdf 1 FINAL PACKAGE INSERT TEXT BETAXONae ae (levobetaxolol hydrochloride ophthalmic suspension) 0.5% as base DESCRIPTION: BETAXONae (levobetaxolol hydrochloride ophthalmic suspension) 0.5% contains levobetaxolol hydrochloride, a cardioselective beta- adrenergic receptor blocking agent, in a sterile resin suspension formulation
http://www.fda.gov/cder/foi/label/2000/21114lbl.pdf page 6
http://www.fda.gov/cder/foi/label/2000/21114lbl.pdf page 2
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt OF IRELAND" 13266 05-Oct-98 FABBRICA ITALIANA SINTETICI SPA "NITROFURANTOIN MONHYDRATE, MANUFACTURED IN VICENZA, ITALY" 13277 22-Oct-98 MATRIX LABORATORIES LIMITED "ACYCLOVIR USP, MANUFACTURED IN ANDHRA PRADESH, INDIA" 13279 19-Oct-98 SYLACHIM DIV FINORGA "LEVOBETAXOLOL HYDROCHLORIDE, MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE" 13282 15-Oct-98 DAICEL CHEMICAL INDUSTRIES LTD...
