Drug Approvals - A Akineton (biperiden HCI) 2 mg Tablets Knoll Pharmaceutical Company NDA 12-003/S-018/S-019/S-020/S-021 & 12-418/S-006/S-007/S-008/S-009 7/23/01 10/10/02 Akineton (biperiden) Tablet, 2 mg Abbott Laboratories NDA 12-003/S-024 2/4/02 4/16/02 - - Alamast (pemirolast potassium ophthalmic solution), 0.1%, Rx Santen Inc
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,...
FDA Drug Approvals List July 2001 PERRIGO COMPANY Active Ingredient(s):ACETAMINOPHEN; ASPIRIN;CAFFEINE OTC/RX Status: RX Labeling Supplements to Original New Drug Applications Application #: 019906 Labeling Supplement#: 009 To Original New Drug Application Approval Date: 31-JUL-01 Trade Name: ANAFRANIL Dosage Form: CAPSULE Applicant: NOVARTIS PHARMACEUTICALS CORP Active Ingredient(s): CLOMIPRAMINE HYDROCHLORIDE ...
FDA Drug Approvals List February 2002 Active Ingredient(s): BUSPIRONE HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application#065022 Approval Date: 27-FEB-02 Trade Name: BACITRACIN ZINC AND POLYMYXIN B SULFATE Dosage Form: OINTMENT Applicant: ALTANA INC Active Ingredient(s): BACITRACIN ZINC; POLYMYXIN B SULFATE OTC/RX Status: RX Original Abbreviated Application# 075874 Approval Date: 26-FEB-02...
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 ...
Anticholinergic agents for Parkinson's disease - [Medication] - Quest Diagnostics Patient Health Library Anticholinergic agents for Parkinson's disease Examples Brand Name Chemical Name Artane, Trihexy-5 trihexyphenidyl hydrochloride Cogentin benztropine mesylate Akineton biperiden hydrochloride Disipal, Norflex orphenadrine citrate Kemadrin procyclidine hydrochloride How It Works Anticholinergic medications block nerve impulses (cholinergic nerve impulses) that help control...
Specificity Table TOX.xls Page 1 Accutane Retinoic acid Keratolytic 100,000 Acetanilide Acetanilide Analgesic 100,000 Acetone Acetone Solvent 10,000,000 Achromycin Tetracycline Antibacterial 100,000 Acriquine Quinacrine Antimalarial 100,000 Actifed Triprolidine Antihistamine 100,000 Actonel Risendronate Bone reabsorption inhibitor 200,000 Acyclovir Acyloguanosine Antiviral 100,000 Adalat Nifedipine...
author: Biosite Incorporated
Specificity Table TOX.xls page 1
author: Biosite Incorporated
Reference Listed Drug Labeling Approved in July 2001 Jul 1 ESTROSTEP 21 letter label norethindrone acetate/ethinyl estradiol tablets 20-130 S-007 Jul 2 ACTOS letter - pioglitazone HCl tablets 21-073 S-011 SANDOSTATIN SANDOSTATIN LAR letter - octreotide acetate injection octreotide acetate injectable suspension 19-667 21-008 S-038 S-003 Jul 3 PROTONIX IV letter - pantoprazole sodium for injection 20-988 S-004 Jul 9 NICOTROL letter -...
author: USERNAME
Reference Listed Drug Labeling Approved in February 2002 Food and Drug Administration • Center for Drug Evaluation and Research Office of Generic Drugs Search Reference Listed Drug Labeling and Efficacy Supplements Approved in February 2002 Click on appropriate hyperlink below to view available source document in PDF format
author: USERNAME
12-003 S-024 AP AKINETON.pdf DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration Rockville MD 20857 NDA 12003/ S- 024 Abbott Laboratories Attention: Ernesto JAkineton (...
author: gracej
12-003 S-024 AP AKINETON.pdf page 1
author: gracej
http://www.fda.gov/cder/foi/appletter/2001/12418s6ltr.pdf Ashworth: Please refer to your supplemental new drug applications dated March 5, 1980 (12- 003/ S- 018 & 12- 418 S- 006), May 1, 1980 (12- 003/ S- 019 & 12- 418 S- 007), September 25, 1985 (12- 003/ S- 020 & 12- 418 S008), and December 10, 1985 (12- 003/ S- 021 & 12- 418 S- 009), submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Akineton (...
http://www.fda.gov/cder/foi/appletter/2001/12418s6ltr.pdf page 2
duplicates:http://www.fda.gov/cder/foi/appletter/2001/12003s18s19s20s21ltr.pdf
http://www.fda.gov/cder/foi/appletter/2001/12418s6ltr.pdf page 1
duplicates:http://www.fda.gov/cder/foi/appletter/2001/12003s18s19s20s21ltr.pdf
http://www.fda.gov/cder/foi/appletter/2001/12003s18s19s20s21ltr.pdf Ashworth: Please refer to your supplemental new drug applications dated March 5, 1980 (12- 003/ S- 018 & 12- 418 S- 006), May 1, 1980 (12- 003/ S- 019 & 12- 418 S- 007), September 25, 1985 (12- 003/ S- 020 & 12- 418 S008), and December 10, 1985 (12- 003/ S- 021 & 12- 418 S- 009), submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Akineton (...
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 at 56- 57oC) 3.00 mL Antirabies Serum 3.00 mL Antitoxin (Gas Gangrene) 3.00 mL Antivenom 3.00 mL Apommorphine HCl Tablets for Injection 0.09 mg Arginine HCl Injection 500.00 mg Ascorbic Acid 4.20 mg Asparaginase for Injection 1000.00 Iu Atracurium Besylate 0.50 mg Atropine Sulfate 0.09 mg Aurothioglucose Suspension 0.70 mg Azathioprine Sodium for Injection 5.00 mg Azlocillin 75.00 mg...
author: FDA / CBER
subject: December 1987 Guideline
http://www.fda.gov/cder/foi/label/2001/17938s22lbl.PDF ENDO LABORATORIES MOBAN ® (Molindone Hydrochloride) Rx only DESCRIPTION MOBAN (molindone hydrochloride) is a dihydroindolone compound which is not structurally related to the phenothiazines, the butyrophenones or the thioxanthenesHYDROCHLORIDE CLINICAL PHARMACOLOGY MOBAN has a pharmacological profile in laboratory animals which predominantly resembles...
