Database E E - 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 To purchase documents on-line click on- link attached to selected document!- The fee is $15 per document Documents are delivered by e-mail...
Database S S - 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.
http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt KG "SELEGILINE HYDROCHLORIDE MANUFACTURED IN MINDEN, FEDERAL REPUBLIC OF GERMANY" 10349 12-Jul-93 BURZYNSKI RESEARCH INSTITUTE INC "ANTINEOPLASTON AS2-1 INJECTIONS MANUFACTURED IN STAFFORD, TEXAS" 10350 23-Jun-93 STAROGARD PHARMACEUTICAL WORKS "TINIDAZOLE MANUFACTURED IN STAROGARD GDANSKI, POLAND" 10353 13-Jul-93 BAYER AG "CIPROFLOXACIN ORAL NEW DRUG SUBSTANCE...
ANDA Approvals - September 2003 9/12/2003- 18 75-145 SELEGILINE HYDROCHLORIDE CAPSULES 5 MG - AAI PHARMA 9/15/2003- 19 75-763 NEFAZODONE HYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG - IVAX PHARMACEUTICALS, INCHYDROCHLORIDE TABLETS 50 MG, 100 MG, 150 MG, 200 MG, AND 250 MG - RANBAXY LABORATORIES LIMITED 9/16/2003- 22 76-037 NEFAZODONE ...
Prescription and Over-the-Counter Drug Product List: 9/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> + MIKART 325MG/15ML;7.5MG/15ML N40482 001 SEP 25, 2003 SEP NEWA ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE TABLET; ORAL >A> OXYCODONE AND ACETAMINOPHEN >A> AA WATSON LABS 325MG;7.5MG N40535 001 SEP 05, 2003 SEP NEWA >A> AA 325MG...
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/ActuationHydrochloride [2 MB] Taro Pharmaceuticals 074694 12/13/1996 12/3/1997 Clomipramine Hydrochloride Capsules, 25, 50, & 75 mg
Prescription and OTC Drug Product List 8/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -A- AA ABLE 300MG;30MG N40452 001 AUG 01, 2002 AUG NEWA -A- AA 300MG;60MG N40459 001 AUG 01, 2002 AUG NEWA ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE TABLET; ORAL ACETAMINOPHEN AND PENTAZOCINE HCL -A- AB AMIDE PHARM 650MG;EQ 25MG BASE N76202 001...
Prescription and OTC Drug Product List 6/2002 -D- + WYETH AYERST 20,000 UNITS/VIAL N17055 003 JUN DISC -A- @ 20,000 UNITS/VIAL N17055 003 JUN DISC CHORIONIC GONADOTROPIN -D- + STERIS 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC -A- @ 2,000 UNITS/VIAL N17016 011 FEB 16, 1990 JUN DISC GRANISETRON HYDROCHLORID E SOLUTION; ORAL KYTRIL -D- + ROCHE EQ 2MG BASE/10ML N21238 001 JUN 27, 2001 JUN DISC -A- @ EQ 2MG BASE/10ML N21238...
Prescription and OTC Drug Product List 4/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL ACETAMINOPHEN, BUTALBITAL, CAFFEINE, AND CODEINE PHOSPHATE -A- AB VINTAGE PHARMS 325MG;50MG;40MG;30MG N75929 001 APR 22, 2002 APR NEWA ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE;...
Export Products List by System July 2003 page 42
author: Lee S. Ehler
74912 Selegiline Hydrochloride Tablets USP Selegiline Hydrochloride Tablets USP Company:- Stason Industrial Corporation Application No.:-ANDA 74-912 Approval Date:- 4/30/98 Approval Letter, Final Printed Labeling, and Chemistry Review(s) (972 KB) Bioequivalence Review(s) Part 1 of 2 (3 MB) Bioequivalence Review(s) Part 2 of 2 (2.7 MB) Administrative Documents and Correspondence Part 1 of 2 (2.4 MB) Correspondence...
author: CDERUSERNAME
Quartely List of Guidance Documents at the Food and Drug Administration page 12
author: FDA
Comprehensive List of Current Guidance Documents at the Food and Drug Administration page 30
author: FDA
Selegiline 6383-05 page 2
author: John J. Carmody
Selegiline 6383-05 page 1
author: John J. Carmody
Prescription and OTC Drug Product List 11/1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 11: Jan '97 - Nov '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE AMANTADINE HYDROCHLORIDE TABLET; ORAL CAPSULE; ORAL PRECOSE - DLT - SYMADINE - DLT - BAYER 25MG N20482 004 - DLT - AB SOLVAY 100MG N71000 001 - DLT - MAY 29, 1997 - DLT - SEP...
Prescription and OTC Drug Product List 12/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 12: December 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST - ADD - ABACAVIR SULFATE ALBUTEROL SULFATE - ADD - SOLUTION; ORAL SOLUTION; INHALATION - ADD - ZIAGEN ALBUTEROL SULFATE - ADD - + GLAXO WELLCOME EQ 20MG BASE/ML N20978 001 - ADD - @ COPLEY PHARM...
Prescription and OTC Drug Product List 11/1998 Prescription and Over-the-Counter Drug Product List - 18th Edition Cumulative Supplement Number 11: November 1998 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE CLOBETASOL PROPIONATE TABLET; ORAL OINTMENT; TOPICAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN EMBELINE - ADD - ENDO PHARMS 400MG;5MG N40288 001 - ADD - AB...
Prescription and OTC Drug Product List 1/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 1: January 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; HYDROCODONE BITARTRATE BENDROFLUMETHIAZIDE; NADOLOL CAPSULE; ORAL TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN CORZIDE - ADD - AA MALLINCKRODT 500MG;5MG N88956 001 - ADD -...
PDPL - ADD - AB1 0.6MG/HR N89774 001 - DLT - SEARLE 0.35MG N17060 001 - ADD - AUG 30, 1996 - ADD - NOR-QD NITRO-DUR - ADD - + SEARLE 0.35MG N17060 001 - DLT - BX + KEY PHARMS 0.1MG/HR N20145 001 - DLT - APR 04, 1995 - DLT - BX + 0.2MG/HR N20145 002 NYSTATIN - DLT - APR 04, 1995 - DLT - BX + 0.4MG/HR N20145 004 POWDER; TOPICAL - DLT - APR 04, 1995 MYCOSTATIN - DLT - BX + 0.6MG/HR N20145...
FDA Drug Approvals List- April 1998 Application #: 020555 Efficacy Supplement#: 003 Type: SE1 to Original New Drug Application Approval Date: 01-APR-98 Trade Name: AXID AR Dosage Form: TABLET Applicant: WHITEHALL ROBINS HEALTHCARE Active Ingredient(s): NIZATIDINE OTC/RX Status: OTC Efficacy Claim: Provides for treatment of episodic heartburn, acid indigestion and sour stomach Application #: 020393 Efficacy Supplement#:...
Drug Approvals January 1997 Drug Approvals for January 1997 Definitions and Notes January 1997 Original New Drug Applications Original Application #: 050733 Approval Date: 30-JAN-97 Trade Name: ZITHROMAX Chemical Type: 3 Therapeutic Potential: S Dosage Form: INJECTABLE Applicant: PFIZER INC Active Ingredient(s): AZITHROMYCIN OTC/RX Status: RX Indication(s): Treatment of patients with community-acquired...
http://www.fda.gov/cber/gdlns/guidelst.txt Drug Advertising and Promotional Labeling DDMAC 2 Dissemination of Reprints of Certain October 8, 1996 Advertising Do Published, Original Data Funded Dissemination of Reference October 8, 1996 Do Do Texts Antifungal (topical) February 24, 1990 Biopharmaceutic Drug Information Branch (Draft) Antifungal (vaginal) February 24, 1990 Do Do Food-Effect Bioavailability and December 30, 1997...
http://www.fda.gov/cber/gdlns/qrtrgde.txt Guidance Documents Issued by the Center for Drug Evaluation and Research (CDER) ---------------------------------------------------------------------------------------------------------------- How to Obtain a Hard Grouped by Intended Copy of the Document Name of Document Date of Issuance User or Regulatory (Name and Address, Activity Phone, FAX, E-mail or Internet) ------------------...
