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 OTC Drug Product List 8/1999 Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 8: August 1999 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE AZATHIOPRINE SODIUM CAPSULE; ORAL INJECTABLE; INJECTION FEMCET IMURAN - DLT - AB MALLINCKRODT 325MG;50MG;40MG N89102 001 - ADD - AP + FARO PHARMS EQ 100MG BASE...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt 4740 19-Oct-82 DIOSYNTH BV DANAZOL 4741 15-Nov-82 FARCHEMIA SRL DOXYLAMINE SUCCINATE USP 4746 09-Dec-82 DIOSYNTH BV BEPRIDIL HYDROCHLORIDE 4754 11-Jan-83 FMC CORP "CELLULOSE ACETATE AS ANALYZED & DISTRIBUTED FROM NEWARK, DELHYDROCHLORIDE AS PROCESSED IN THE INGELHEIM PLANT 5381 01-Jun-84 ALBEMARLE CORP "IBUPROFEN AS MANUFACTURED IN THE ORANGEBURG...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls DSM PHARMA CHEMICALS SOUTH HAVEN INC PARA-AMINOHIPPURIC ACID USP XX - MANUF IN SOUTH HAVEN, MICHIGAN TAKEDA CHEMICAL INDUSTRIES LTD PYRIDOXINE HYDROCHLORIDE COSMA SPA HYDROXYZINE PAMOATE PROFARMACO SRL LORAZEPAM ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV PRAMOXINE HCL AS MANFDOXYLAMINE SUCCINATE USP DIOSYNTH BV...
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...
PMS International EXPORT DIVISION LICENSING DIVISION EASTERN EUROPE DIVISION EXPORT CATALOG (PDF - Sorted by System) EXPORT CATALOG (PDF - Alphabetically sorted) LICENSING CATALOG EASTERN EUROPE CATALOG - - The following products are presently supplied to the customers in Eastern Europe: PMS BRAND NAME OTHER NAME OR COMPOSITION - DOSAGE FORM - PACK SIZE - AMITRIPTYLIN Amitriptylin 10 mg or 25 mg - -...
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
FDA Drug Approvals List May 2002 - Drug Approvals for May 2002 Definitions and Notes Original New Drug Applications Original Abbreviated Antibiotic Application # 065082 Approval Date: 31-MAY-02 Trade Name: CEFPODOXIME PROXETIL Dosage Form: GRANULE, FOR RECONSTITUTION Applicant: RANBAXY LABORATORIES LTD Active Ingredient(s): CEFPODOXIME PROXETIL OTC/RX Status: RX Original Application #: 021292 Approval Date: 31-MAY...
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...
Drug Approvals September 1996 CATARRHALIS TO THE INDICATIONS AND USAGE SECTION Approvable Original New Drug Applications Original Application #: 020535 Approvable Date: 30-SEP-96 Trade Name: DURACT Dosage Form: CAPSULE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): BROMFENAC SODIUM OTC/RX Status: RX Original Application #: 020690 Approvable Date: 19-SEP-96 Trade Name: ARICEPT Dosage Form: TABLET...
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
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 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...
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http://www.plantsci.cam.ac.uk/plantsci/admin/forms/ChemCategD.pdf page 4 4 PHENYL SEPHAROSE PHENYLALANINE ( L, D, or D/ L) PHLEOMYCIN PHOSPHATIDIC ACIDS (L- a-) PHOSPHATIDYL INOSITOL PHOSPHATIDYLCHOLINE / LECITHIN PHOSPHATIDYLETHOLAMIDE LPHOSPHATYDYLCHOLINE DIPALMITOYL (LPHOSPHOENOLPYRUVATE / PEP PHOSPHOGLUCONIC ACID PHOSPHOGLYCERIC ACID (D(-) 3-) PHOSPHOGLYCOLIC ...
