|
|
|
|
http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN PHENAPHEN-650 W/ CODEINE, ACETAMINOPHEN PHENAZINE, PHENDIMETRAZINE TARTRATE PHENAZINE-35, PHENDIMETRAZINE TARTRATE PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE PHENERGAN FORTIS, PROMETHAZINE HYDROCHLORIDE PHENERGAN PLAIN, PROMETHAZINE HYDROCHLORIDE PHENERGAN VC W/ CODEINE, CODEINE PHOSPHATE PHENERGAN VC, PHENYLEPHRINE HYDROCHLORIDE PHENERGAN W/ CODEINE, CODEINE...
|
|
|
material_safety_data_sheet_letter_new_.doc
05% OCUFLOX® (Ofloxacin Ophthalmic Solution) 0.3% SANCTURA® (trospium chloride), 20 mg tablets Ofloxacin SANCTURA XR® (trospium chloride), 60 mg tablets OPHTHETIC® (Proparacaine HCl Ophthalmic Solution) 0.5% Trimethoprim Sulfate and Polymyxin B Sulfate, 0.1% OPTIVE™ Lubricant Eye Drops VIVITE™ Daily Antioxidant Facial Serum POLY- PRED&...
author: hutton_ronald
|
|
|
material_safety_data_sheet_letter_new_.doc page 2
author: hutton_ronald
|
|
|
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
|
|
|
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
AMIODARONE HCL 3506 24-Apr-79 BAXTER ONCOLOGY GMBH IFOSFAMIDE 3507 27-Apr-79 GEDEON RICHTER LTD VINCRISTINE SULFATE 3513 08-Mar-79 FABBRICA ITALIANI SINTETICI SPA FUROSEMIDE 3516 30-Mar-79 DINAMITE DIPHARMA SPA TRIAMTERENE USP XIX/BP '73 3524 08-Feb-79 DINAMITE DIPHARMA SPA "CYPROHEPTADINE HCL, USP" 3529 30-May-79 AVENTIS PHARMA SA PREDNISOLONE ACETATE 3531 14-Mar...
|
|
|
Prescription and Over-the-Counter Drug Product List: 6/2003
>D> AP + WYETH AYERST 5,000 UNITS/VIAL N17055 001 JUN DISC >A> @ 5,000 UNITS/VIAL N17055 001 JUN DISC >D> AP + 10,000 UNITS/VIAL N17055 002 JUN DISC >A> @ 10,000 UNITS/VIAL N17055 002 JUN DISC GUANABENZ ACETATE TABLET; ORAL GUANABENZ ACETATE >D> AB WATSON LABS EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >A> AB + EQ 8MG BASE N74025 002 FEB 28, 1994 JUN CRLD >D> WYTENSIN ...
author: AUTHOR
|
|
|
SSCI Inc.: X-ray Powder Diffraction, Raman and Infrared Spectroscopy, Differential Scanning Calorimetry, and Thermogravimetric
Phone: 800 375-2179 / 765 463-0112 Fax: 765 497-2649 / 765 463-4722 E-mail: info@ssci-inc.com SSCI Inc., 3065 Kent Avenue, West Lafayette, IN 47906 - 1076 USA Acetaminophen Acetazolamide Acetohexamide Acetylcysteine Acyclovir Adenine L-Alanine Albuterol Albuterol Sulfate Allopurinol Alprazolam Amantadine HCl Amiloride HCl Aminobenzoic Acid Aminoglutethimide Aminosalicylic Acid...
author: SSCI Webmaster
|
|
|
Prescription and OTC Drug Product List 5/2001
IRRIGANT NYSTATIN - ADD - MONARCH PHARMS EQ 40MG BASE/ML; - ADD - @ TEVA 100,000 UNITS/GM N61966 001 - ADD - 200,000 UNITS/ML N60707 001 OINTMENT; TOPICAL - DLT - NILSTAT NETILMICIN SULFATE - DLT - AT + LEDERLE 100,000 UNITS/GM N61444 001 - ADD - @ 100,000 UNITS/GM N61444 001 - DLT - INJECTABLE; INJECTION NYSTATIN - DLT - NETROMYCIN - DLT - AT ALTANA 100,000 UNITS/GM N62124 002...
|
|
|
Prescription and OTC Drug Product List 2/2001
PEDIATRIC - ADD - @ 10MG;100MG N74080 001 - ADD - + ASTRAZENECA /1VIL;0.02MG/VIAL;0.001MG/VIAL; - ADD - MAR 25, 1994 - ADD - 5MG/VIAL;0.01MG/VIAL;0.14MG/VIAL; - ADD - @ 25MG;100MG N74080 002 - ADD - 17MG/VIAL;0.2MG/VIAL; - ADD - MAR 25, 1994 - ADD - EQ 1MG BASE/VIAL;1.4MG/VIAL; - ADD - @ 25MG;250MG N74080 003 - ADD - EQ 1.2MG BASE/VIAL;0.7MG/VIAL; - ADD - MAR 25, 1994 - ADD - 7MG...
|
|
|
http://www.fda.gov/cber/gdlns/guidelst.txt
Preliminary Guidance Implementation Plan USP injection October 2, 1995 Do Do nomenclature In Vivo Bioequivalence Studies of April 22, 1996 Do Do Clozapine Instructions for Filing Supplements April 11, 1996 Do Do Under the Provisions of SUPAC-IR Seventh of a series of letters about July 29, 1988 Do Do the Act providing guidance on the ``180-day exclusivity'' provision of section 505(j...
|
|
|
http://www.fda.gov/cber/gdlns/anguidlst.txt
Preliminary Guidance -------------------------------------------------------------------------------------------------------------------------------------------------------- Implementation Plan USP injection nomenclature October 2, 1995 Do Do -----------------------------------------------------------------------------------------------------------------------------------------------...
|
|
|
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 5
author: FDA / CBER
subject: December 1987 Guideline
|
|
|
material_safety_data_sheet_letter_new_.doc page 1
author: hutton_ronald
|
|
|
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...
|
|
|
Prescription and Over-the-Counter Drug Product List: 4/2003
45 -D- XCEL PHARMS 1MG/ML N05929 001 APR CFTG -A- AP + 1MG/ML N05929 001 APR CFTG -A- DIHYDROEROGTAMINE MESYLATE -A- AP PADDOCK 1MG/ML N40475 001 APR 28, 2003 APR NEWA DILTIAZEM HYDROCHLORIDE CAPSULE, EXTENDED RELEASE; ORAL -A- TAZTIA XT -A- AB4 ANDRX PHARMS 120MG N75401 001 APR 10, 2003 APR NEWA -A- AB4 180MG N75401 002 APR 10, 2003 APR NEWA -A- AB4 240MG N75401 003 APR 10, 2003 APR...
author: AUTHOR
|
|
|
Prescription and Over-the-Counter Drug Product List: 2/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004 FEB 03, 2003...
author: AUTHOR
|
|
|
CDER Guidance Documents
(Issued 8/2000, Posted 8/8/2000) Joint Safety/Efficacy (Multidisciplinary) (Draft) M2 Electronic Common Technical Document Specification [ HTML ] or [ PDF ] (Issued 6/2002, Posted 6/13/2002) 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...
|
|
|
Prescription and OTC Drug Product List 1/2000
Prescription and Over-the-Counter Drug Product List - 20th Edition Cumulative Supplement Number 1: January 2000 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST 1 20TH EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST / CUMULATIVE SUPPLEMENT NUMBER 1 / JAN'2000 - ADD - CALCIUM CHLORIDE CEFTIBUTEN DIHYDRATE - ADD -...
|
|
|
C:\LORI\ALLERGAN\50612 s014 AP ltr cmc & label 10-15-03.doc page 5
author: Lori Gorski
|
|
|
C:\LORI\ALLERGAN\50612 s014 AP ltr cmc & label 10-15-03.doc page 3
author: Lori Gorski
|
|
|
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004
FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -OGD Suitability Tracking Report (Sorted by Petition Number) as of 1/5/2004 Drug/Strength Petition No/Firm Dosage Form Status Status Date ACETAMINOPHEN 300 MG HYDROCODONE BITARTRATE 5 MG, 7.5 MG, 10 MG - 03P-0436/CP1 ANABOLIC LABORATORIES - - - 9/22/2003- TRIPELENNAMINE HYDROCHLORIDE 25 MG/5...
|
|
|
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004
- SOLUTION; ORAL Approved 4/17/2001- HYDROCODONE POLISTIREX 5 MG, 10 MG CHLORPHENIRAMINE POLISTIREX 4 MG, 8 MG - 03P-0091/CP1 LACHMAN CONSULTANT SERVICES - EXTENDED RELEASE CAPSULES Pending - HYDROCORTISONE ACETATE 2% - 01P-0085/CP1 FERNDALE LABORATORIES INC
- CREAM; TOPICAL Approved 8/1/2001- HYDROCORTISONE ACETATE 2.5% - 01P-0511/CP1 FERNDALE LABORATORIES, INC
-...
|
|
|
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)
74579 11/26/97 4/7/99 Bleomycin Sulfate - Pharmacia 064084 06/03/1996 8/4/2003 Brompheniramine Chromalloy Pharmaceuticals 085888 04/26/1978 8/6/2003 Bumetanide Injection USP, 0.25 mg/mL
71804 5/29/1997 4/1/1999 Desmopressin Acetate Injection 4mg/ml [801 KB] Gensia Laboratories, Ltd
Perrigo Company 40167 9/15/96 4/13/99 Epifoam/Hydrocortisone Acetate 1% and...
|
|
|
FDA Drug Approvals List July 2002
- Drug Approvals for July 2002 Definitions and Notes Original New Drug Applications Original New Drug Application # 021409 Approval Date: 26-JUL-02 Trade Name: SINGULAIR Chemical Type: 3 Therapeutic Potential: S Dosage Form: GRANULE Applicant: MERCK RESEARCH LABORATORIES DIV MERCK CO INC Active Ingredient(s): MONTELUKAST SODIUM OTC/RX Status: RX Indication of Use: PROPHYLAXIS/CHRONIC...
|
