Database C C - investigational drugs, therapies and vaccines # - A - B - C - D - E - F - G - H - I - J - K - L - M - N - O - P - Q - R - S - T - U - V - W - X - Y - Z From this page you may order documents with information covering investigational products.Hydrochloride) (2400) Calanolide A (1030)...
Drug Approvals - D ANDA 75-371 8/27/99 9/2/99 - - Dacarbazine for Injection USP, 200 mg/vial, Rx Gensia Sicor Pharmaceuticals ANDA 75-259 8/27/98 9/2/98 - - Dalmane (flurazepam hydrochloride) Capsules, 15 mg and 30 mg ICN Pharmaceuticals NDA 16-721/S-074 6/14/01 11/22/02 Daraprim (pyrimethamine) Tablets, 25 mg, Rx GlaxoSmithKline NDA 8-578/S16 11/18/03 11/25/03 12/1/03 - Daraprim (pyrimethamine)...
What's new at CDER by Date New and Generic Drug Approvals Benazepril Hydrochloride Tablets, Mylan Pharmaceuticals Benazepril Hydrochloride Tablets, Ranbaxy Benazepril Hydrochloride Tablets, Andrx Pharmaceuticals Benazepril Hydrochloride Tablets, Genpharm Benazepril Hydrochloride Tablets, Ivax Pharmaceuticals Benazepril Hydrochloride Tablets, Teva Pharmaceuticals Benazepril ...
author: Paul Stauffer
FACT SHEET Stability Time for Maxipime Admixture and IV Infusion RT/ L Refrigeration Concentration Concentration Solutions (20°TH 25° C) (2°TH 8° C) 40 mg/ mL Amikacin NS or D5W 24 hours 7 days 6 mg/ mL 40 mg/ mL Ampicillin D5W 8 hours 8 hours 1 mg/ mL 40 mg/ mL Ampicillin D5W 2 hours 8 hours 10 mg/ mL 40 mg/ mL Ampicillin NS 24 hours 48 hours 1 mg/ mL 40 mg/ mL Ampicillin...
author: K. Notarianni
FACT SHEET page 6
author: K. Notarianni
duplicates:http://www.elan.com/Images/Maxipime_PI_200204_tcm3-4348.pdf
MAX0173 Full PI-4 pager Stability Time for Maxipime Admixture and IV Infusion RT/ L Refrigeration Concentration Concentration Solutions (20°TH 25° C) (2°TH 8° C) 40 mg/ mL Amikacin NS or D5W 24 hours 7 days 6 mg/ mL 40 mg/ mL Ampicillin D5W 8 hours 8 hours 1 mg/ mL 40 mg/ mL Ampicillin D5W 2 hours 8 hours 10 mg/ mL 40 mg/ mL Ampicillin NS 24 hours 48 hours 1 mg/ mL 40 mg/ mL Ampicillin...
author: Freelance
CDER Guidance Documents (Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (Issued 9/2001, Posted 9/5/2001) [ PDF ] M4 Common Technical Document--Quality: Questions and Answers/Location Issues [ HTML ] or [ PDF ] or [ ] (Issued 9/12/2002, Posted 12/30/2002) Quality Q1E Evaluation of...
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 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 ...
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
ANDAs Approvals - May 2000 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Office Of Generic Drugs ANDAs Approvals May 2000 - 1HYDROCHLORIDE GENPHARM INCHYDROCHLORIDE EON LABS MANUFACTURING, 5/1/00 TABLETS 80 MG 120 MG 160 MG INCHYDROCHLORIDE ...
author: USERNAME
First-Time Generics - February 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - February 2001 DRUG NAME ANDA NUMBER SUPPLEMENT NUMBER APPROVAL DATE CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 150 MG (BASE) 300 MG (BASE) 65-061 - 2/2/01 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS, USP 1.0 MG/0.02 MG) 75-647 - 2/5/01...
author: USERNAME
First-Time Generics -June 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - June 2001 Approval Date Drug Name ANDA Number Supplement Number 6/7/01 METHIMAZOLE TABLETS, USP 20 MG 40-350 S-001 6/15/01 LOVASTATIN TABLETS, USP 10 MG, 20 MG, AND 40 MG 75-451 6/26/01 TERBUTALINE SULFATE TABLETS, USP 2.5 MG, AND 5 MG 75-877 6/28/01 BUSPIRONE ...
author: USERNAME
First-Time Generics - January 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - January 2002 Generic Name Brand Name Approval Date 1 SULFASALAZINE DELAYED-RELEASE TABLETS, USP 500 MG AZULFIDINE EN-TABS 1/11/02 2 OFLOXACIN INJECTION 40 MG/ML (10 ML SINGLE-DOSE VIALS) FLOXIN I.VHYDROCHLORIDE TABLETS 500...
author: USERNAME
Efficacy Supplements Approved in Calendar Year 1998 CLINDAMYCIN PHOSPHATE PHARMACIA AND UPJOHN 50-680 08-May-95 02-Mar-98 SE2 33.8 Provides for a 3-day dosing regimen of 2% clindamycin phosphate vaginal cream in the treatment of bacterial vaginosisHYDROCHLORIDE BIOVAIL LABS 20-401 30-Jan-97 30-Jan-98 SE1 12.0 Treatment of chronic stable anginaHYDROCHLORIDE LILLY 20-509 29-Aug-97 25...
author: Brenda Harmon
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
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/ActuationClindamycin Phosphate Topical Swab (Pledgets)], 1% (base)Hydrochloride [2 MB] Taro Pharmaceuticals...
ANDA Approvals February 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Approvals February 2001 ANDA NUMBER DRUG- NAME APPLICANT APPROVAL DATE 1 65-061 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 150 MG (BASE)------- 300 MG (BASE) RANBAXY LABORATORIES LIMITED 2/2/01 2 75-738 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/650 MG MALLINCKRODT...
author: USERNAME
ANDA Approvals June 2001 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Approvals - June 2001 - ANDA Number Drug Name Applicant Approval Date 1 40-374 TRIAMCINOLONE ACETONIDE OINTMENT, USP 0.025% THAMES PHARMACAL CO., INC
author: USERNAME
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:...
FDA Drug Approvals List July 2002 45 Dosage Form: INJECTABLE Applicant: XCEL PHARMACEUTICALS Active Ingredient(s): DIHYDROERGOTAMINE MESYLATE OTC/RX Status: RX Application #: 020449 Labeling Supplement #: 019 To Original New Drug Application Approval Date: 30-JUL-02 Trade Name: TAXOTERE Dosage Form: INJECTABLE Applicant: AVENTIS PHARMACEUTICALS INC Active Ingredient(s): DOCETAXEL OTC/RX Status: RX Application #:...
FDA Drug Approvals List January 2002 - Drug Approvals for January 2002 Definitions and Notes Original New Drug Applications Efficacy Supplemental New Drug Applications Application #: 020837 Efficacy Supplement #: 006 Type: SE5 to Original New Drug Application Approval Date: 30-JAN-02 Trade Name: XOPENEX Dosage Form: SOLUTION Applicant: SEPRACOR, INC Active Ingredient(s): LEVALBUTEROL HYDROCHLORIDE OTC/RX Status:...
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...
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...
