Drug Approvals - B Betaseron Interferon beta-1b - - Chiron Corp BLA 103471 / 5032 10/10/03 10/31/03 10/31/03 - Betaxolol Hydrochloride Tablets USP, 10 mg and 20 mgBetaxolol Ophthalmic Solution USP, 0.5%, Rx, Tentatively approved Bausch & Lomb Pharmaceuticals, IncBetaxolol Ophthalmic Solution USP, 0.5%, Rx...
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 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,...
1999 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 1/21/99 1/26/99 Prograf (tacrolimus) capsules Fujisawa USA DDMAC 1/4/99 1/11/99 Remeron (mitrazapine) tablets Organon DDMAC 1/5/99 1/14/99 Risperdal (risperidone) tablets and oral solution Janssen Research DDMAC 1/5/99 1/14/99 Trivora, Zovia, Necon, Levora, Nor-QD Tablets Watson Laboratories DDMAC 1/26/99 2/12/99 February Arava (leflunomide) tablets Hoechst Marion Roussel DDMAC...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "TERAZOSIN HCL-FORM 1, MANUFACTURED IN VARESE, ITALY" 12585 09-Jul-97 ACS DOBFAR SPA "SODIUM BICARBONATE, STERILE, MANUFACTURED IN MILANO, ITALY" 12586 09-Jul-97 ACS DOBFAR SPA "CEPHALOTHIN SODIUM, ORAL GRADE, MANUFACTURED IN MILANO, ITALY" 12589 11-Jul-97 ORION CORP FERMION "AZATHIOPRINE, MANUFACTURED IN OULU, FINLAND" 12596 18-Jul-97 AMCIS AG "TROPICAMIDE, MANUFACTURED IN BUDENDORF...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls IN BUDAPEST, HUNGARY PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE AVENTIS PHARMA SA PROMETHAZINE HCL GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK SCHERING AG ETHINYL ESTRADIOL ROCHE COLORADO CORPORATIONHYDROCHLORIDE (LA 6023) BOEHRINGER INGELHEIM CHEMICALS INC...
OGD, First Time Approvals - June 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office of Generic Drugs Approved Drugs First Time Generic June 2000 Established Name/Dosage Form and AP Date MIDAZOLAM HYDROCHLORIDE INJECTION 1 MG (BASE)/ML (SYRINGE) 5 MG (BASE)/ML 6/20/00 (SYRINGE) HYDROXYUREA CAPSULES, USP 250 MG 6/26/00 AMIODARONE HYDROCHLORIDE TABLETS...
author: USERNAME
ANDAs Approvals - June 2000 40-372 PROMETHAZINE ABBOTT LABORATORIES 6/8/00 HYDROCHLORIDE INJECTION, USP 25 MG/ML (SYRINGE) 50 MG/ML (SYRINGE) 3HYDROCHLORIDE MALLINCKRODT INCHYDROCHLORIDE INJECTION 1 MG (BASE)/ML (VIALS) 5 MG (BASE)/ML (VIALS) 8HYDROCHLORIDE INJECTION 1 MG (BASE)/ML (VIALS) 5 MG (BASE)/ML ...
author: USERNAME
ANDA Approvals April 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Approvals April 2001 - ANDA Number Drug Name Applicant Approval Date 1 75-547 THIOTEPA FOR INJECTION, USP 15 MG/VIAL BEDFORD LABORATORIES 4/2/01 2 75-498 TERAZOSIN HYDROCHLORIDE CAPSULES 1 MG (BASE) 2 MG (BASE) 5 MG (BASE) 10 MG (BASE) TORPHARM 4/12/01 3 75-630 BETAXOLOL ...
author: USERNAME
FDA Drug Approvals List April 2001 - Drug Approvals for April 2001 Definitions and Notes Original New Drug Applications Original Application #: 020949 Approval Date: 30-APR-01 Trade Name: ACCUNEB Chemical Type: 5 Therapeutic Potential: S Dosage Form: SOLUTION Applicant: DEY LABORATORIES INC Active Ingredient(s): ALBUTEROL SULFATE OTC/RX Status: RX Indication(s): For the treatment of asthma-related bronchospasm in...
Prescription and OTC Drug Product List 6/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA PEACHTREE 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN -A- AA UCB 500MG;10MG N40210 001 AUG 13, 1997 JUN CAHN ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL DARVOCET -A- @ AAIPHARMA LLC 325MG;32.5MG N16844 001 JUN CAHN ...
FDA Drug Approvals List April 2000 Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074657 Approval Date: 28-APR-00 Trade Name: TERAZOSIN HCL Dosage Form: TABLET Applicant: INVAMED INC Active Ingredient(s): TERAZOSIN HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application# 065041 Approval Date: 28-APR-00 Trade Name:...
Prescription and OTC Drug Product List 9/2000 Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 9: September 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE - ADD - ARSENIC TRIOXIDE TABLET; ORAL - ADD - INJECTABLE; INJECTION HYDROCODONE BITARTRATE AND ACETAMINOPHEN - ADD - TRISENOX - ADD - AA MALLINCKRODT 325MG...
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...
Drug Approvals for April 1997 Drug Approvals for April 1997 Definitions and Notes April 1997 Original New Drug Applications Original Application #: 020619 Approval Date: 17-APR-97 Trade Name: BETOPTIC PILO Chemical Type: 4 Therapeutic Potential: S Dosage Form: SUSPENSION/DROPS Applicant: ALCON LABORATORIES INC Active Ingredient(s): BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE OTC/RX Status...
FDA Drug Approvals List September 2000 Original Application #: 021251 Approval Date: 15-SEP-00 Trade Name: KALETRA Chemical Type: Therapeutic Potential: Dosage Form: SOLUTION Applicant: ABBOTT LABORATORIES Active Ingredient(s): LOPINAVIR OTC/RX Status: RX Indication(s): For the treatment of HIV-1 infection in adults and pediatric patients age six months and older Original Application #: 021226 Approval Date: 15-SEP-00...
http://www.fda.gov/cder/foi/appletter/1999/75441ltr.pdf ANDA 75- 541 October 22, 1999 Amide Pharmaceutical, IncBetaxolol Hydrochloride Tablets USP, 10 mg and 20 mg
http://www.fda.gov/cder/foi/appletter/1999/75441ltr.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...
DDPA August 1996 20-619 BETOPTICPILO ALCON BETAXOLOL HYDROCHLORIDE 01-AUG-96 (SUSPENSION) FORT WORTH, TX 0.25% 76134 PILOCARPINE HYDROCHORIDE 1.75% (ADRENOCEPTOR ANTAGONIST/ CHOLINERGIC AGONIST) 20-587 SCLEROSOL BRYAN TALC 09-AUG-96 (AEROSOL, POWDER) WOBURN, MA 4GM 01801 (MINERAL) 20-592 ZYPREXA LILLY OLANZAPINE 30-AUG-96 (TABLET) INDIANAPOLIS, IN 2.5MG 46285 5MG 7.5MG 10MG (ANTIPSYCHOTIC...
Drug Approvals December 1996 Drug Approvals for December 1996 Definitions and Notes December 1996 Original New Drug Applications Original Application #: 020681 Approval Date: 31-DEC-96 Trade Name: ORTHO TRI-CYCLEN Chemical Type: 6 Therapeutic Potential: S Dosage Form: TABLET Applicant: RW JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE DIV ORTHO PHARMACEUTICAL CORP Active Ingredient(s): ETHINYL ESTRADIOL; NORGESTIMATE...
August Drug Approvals Original Application #: 020508 Approval Date: 29-AUG-96 Trade Name: LAC-HYDRIN Chemical Type: 3 Therapeutic Potential: S Dosage Form: CREAM Applicant: BRISTOL MYERS CO Active Ingredient(s): AMMONIUM LACTATE OTC/RX Status: RX Indication(s): ICHTHYOSIS VULGARIS AND XEROSIS Original Application #: 020532 Approval Date: 26-AUG-96 Trade Name: IVY BLOCK Chemical Type: 1 Therapeutic...
Generic Names of Some Trade Name Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs -~ Generic Names of Some Trade Name Drugs - Generic Names of Some...
Some Trade Names of Generic Drugs, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - APPENDIX I - Drug Names: Generic and Trade TOPICS - Introduction -~ Some Trade Names of Generic Drugs-~ Generic Names of Some Trade Name Drugs - Some Trade Names of...
Index B, THE MERCK MANUAL OF HEALTH & AGING Committed to Providing Medical Information Table of Contents Index Enlarge Text Reset Text Shrink Text -- Buy the Book Learn about participating in clinical trials at this government website: www.clinicaltrials.gov - INDEX - Index-A -~ Index-B-~ Index-C -~ Index-D -~ Index-E -~ Index-F -~ Index-G -~ Index-H -~ Index-I -~ Index-J -~ Index-K -~ Index-L -~ Index-M -~ Index-N -~ Index-O ...
