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,...
2003 Export Products List Alphabetical ORDER # pms- PRODU TS FORMAT OMPARABLE TO LASSIFI ATION ( System): INDI ATIONS PRODU TS AVAILABLE FOR EXPORT Effe tive: July 2003 LISTINGS IN RED ARE C NTR LLED DRUGS Page: 9 pms- holestyramine - pms- o aine Powder 5760633300 N Covan Syrup 100 mL C0- Actifed Syrup Cough Syrup (Codeine Phosphate, Triprolidine Hydrochloride, 5760633301 N Covan Syrup 500 mL Pseudoephedrine ...
author: Lee S. Ehler
Published in FEDERAL REGISTER in 2000 (Volume 65) Index of Significant OTC Drug Federal Register Publications 1990 – 2003 (Volumes 55 – 68) Updated April 2003 Division of Over- the- Counter Drug Products Office of Drug Evaluation V Center for Drug Evaluation and Research Food and Drug Administration 5600 Fishers Lane (HFD- 560) Rockville, MD 20850 Index of Significant OTC Drug Federal Register Publications Page 1 Table of...
author: CDER USER
duplicates:http://www.fda.gov/cder/Offices/OTC/significant_publications_6-13-2003.pdf
OTC Drug Review Ingredient Status AA ANTACID AB ANTIBIOTIC AC ANTICARIES AD ANTIDIARRHEAL AE ANTIEMETIC AF ANTIFUNGAL AH ANTHELMINTIC AK ACNE AL ALCOHOLS (TOPICAL) AM ANTIMICROBIAL AN ANTIFLATULENT AP ANTIPERSPIRANT AR ANORECTAL AS ASTRINGENT AT ACUTE TOXIC INGESTION AX APHRODISIAC BT BOIL TREATMENT BP BENIGN PROSTATIC HYPERTROPHY CA COUGH COLD (ANTICHOLINERGIC) CB COUGH COLD (BRONCHODILATOR) CC COUGH COLD ...
author: Paul Stauffer
A:\SIGNPUBL.RPT PR 10- 26- 82 47FR47520 Bronchodilator PR 1- 25- 83 48FR3382 Bronchodilator correction 4- 29- 83 48FR19470 Metaproterenol meeting notice 5- 6- 83 48FR20502 Republishing of meeting notice 6- 3- 83 48FR24925 Decision on Metaproterenol 8- 30- 83 48FR39242 Antiasthmatic PR and reopening of record 9- 19- 83 48FR41786 Bronchodilator correction 10- 19- 83 48FR48576 Antitussive PR 11-...
author: Paul Stauffer
A:\SIGNPUBL.RPT page 10
author: Paul Stauffer
Specificity Table TOX.xls Tested (ng/ ml) Mikedimide Bemegride Analeptic 100,000 Milontin Phensuximide Anticonvulsant 500,000 Miltown Meprobamate Sedative 100,000 Minipress Prazosin Antihypertensive 100,000 Miolene Ritodrine Tocolytic 100,000 Moderil Rescinnamine Antihypertensive 500,000 Mogadon Nitrazepam Benzodiazepine 100,000 BZO 2,600 Mogadon metabolite Nitrazepam metab.( 2- Amino- 5- Nitrobenzophenone)...
author: Biosite Incorporated
Rulemaking History for OTC Cold & Cough Drug Products Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Rulemaking History for OTC Cold and Cough Drug Products Final Monograph (21CFR341):-- Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use [ PDF ] [ HTML ] - Date Federal Register Citation Action 9/9/1976 41FR38312 Advance Notice of...
author: USERNAME
Rulemaking History for OTC Antitussive Drug Products Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Rulemaking History for OTC Antitussive Drug Products Final Monograph (21CFR341):-- Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use [ PDF ] [ HTML ] - Date Federal Register Citation Action 9/9/1976 41FR38312 Advance Notice of...
author: USERNAME
http://www.fda.gov/cder/otcmonographs/Cold&Cough/cold&cough_FR_20021206.htm Table 1.--Warning for Oral Antiemetic, Antihistamine, Antitussive, and Nighttime Sleep-Aid Drug Products Containing Diphenhydramine Ingredients ------------------------------------------------------------------------ Warnings ---------------------------------------- Do not use [sbull] with any other product containing diphenhydramine, even one used on skin ---------------...
Document page 3
author: U.S. Government Printing Office
subject: Extracted Pages
Allergy [Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2001] From the U.SAntitussive active ingredientsDiphenhydramine citrateDiphenhydramine hydrochlorideAntitussive active ingredientsDiphenhydramine citrateDiphenhydramine hydrochloride
Document 235 Food and Drug Administration, HHS PtAntitussive active ingredientsDiphenhydramine citrateDiphenhydramine hydrochlorideAntitussive active ingredientsDiphenhydramine citrate...
author: U.S. Government Printing Office
subject: Extracted Pages
Document page 2
author: U.S. Government Printing Office
subject: Extracted Pages
Document page 3
author: U.S. Government Printing Office
subject: Extracted Pages
http://www.fda.gov/cder/otc/milestone.pdf Limits 5/ 10/ 96 11/ 18/ 96 Anorectal 5/ 27/ 80 8/ 15/ 88 8/ 3/ 90 310.545 Listing (LYCD) 9/ 2/ 93 Witch Hazel Name Change 6/ 3/ 94 Antacid 4/ 5/ 73 11/ 12/ 73 6/ 4/ 74 In Vitro Test 5/ 27/ 80 8/ 31/ 82 Statement of Identity/ Upset Stomach 9/ 21/ 79 8/ 31/ 82 Exemption/ Accidental Overdose 4/ 13/ 84 8/ 1/ 86 Combo/ Antacid & Analgesic 11/ 16/ 88 Relief of Upset Stomach/...
http://www.fda.gov/cder/otc/milestone.pdf page 2
OTC Drug Review Ingredient Status page 3
author: Paul Stauffer
Significant Publications 1970 s 9- 9- 76 38312 Cough, Cold, Allergy, Bronchodilator and Antiasthmatic (341) (P) 11- 30- 76 52536 Decision on Diphenhydramine as an Antitussive (N) 11- 30- 76 52537 Benylin Expectorant: NOH on Proposal to Deny Approval of Supplemental NDA for OTC Marketing as an Antitussive (N) 12- 10- 76 54032 Decision of Theophylline as a Single Ingredient-- Disagreement with 9- 9-...
author: Paul Stauffer
Significant Publications 1970 s page 4
author: Paul Stauffer
Nuova pagina 1 OUR EXPERIENCE - YOUR ADVANTAGE PRODUCTS & SERVICES ORGANISATION HOME PAGE WORLD - WIDE CO-OPERATION INDUSTRIAL TECHNOLOGIES FERMENTATION TECHNOLOGIES SEMI-SYNTHETIC ANTIBIOTICS SYNTHETIC PRODUCTS E-MAIL info@biofinlabs.com - ASPARTAME Sweetner Yield w/w on Phenylalanine = 1.06------------------------------------ AZEPETINE PHOSPHATE Anti-adrenergic Yield w/w on metanitroroluol = 0.33...
PROTUSS D LIQUID PROTUSS ® – D LIQUID C- III Rx Only DESCRIPTION: A clear, colorless, sweet tasting liquid for oral administration, which is SugarFree, Alcohol- Free, Corn- Free, and Dye FreeAntitussive, Nasal Decongestant, and ExpectorantHydrochloride is a sympathomimetic...
author: YPreston
PROTUSS D LIQUID page 1
author: YPreston
FDA DRUG AND DEVICE PRODUCT APPROVALS 19-815 PROAMATINE ROBERTS PHARM MIDODRINE HYDROCHLORIDE 06-JUN-96 (TABLET) EATONTOWN, NJ 2.5MG 07724 5MG (ANTIHYPOTENSIVE) 20-519 LOPROX HOECHST MARION RSSL CICLOPIROX 02-JUL-96 (GEL) BRIDGEWATER, NJ 0.77% 08807 (ANTIFUNGAL) 20-584 LODINE XL WYETH AYERST ETODOLAC 03-JUL-96 (TABLET, PHILADELPHIA, PA 400MG EXTENDED RELEASE) 19101 600MG (NONSTEROIDAL ANTI-INFLAMMATORY) 20-453...
http://www.fda.gov/cder/da/ddpa93.wpd 20 198 NIFEDIPINE MILES NIFEDIPINE 01 29 93 (TABLET, WEST HAVEN, CT 30MG EXTENDED RELEASE) 06516 60MG 90MG (CALCIUM ION INFLUX INHIBITOR) 20 288 MONISTAT 7 ADVANCED CARE MICONAZOLE NITRATE 01 29 93 COMBINATION PACK RARITAN, NJ 100MG-SUPPOSITORY (SUPPOSITORY/CREAM) 08869 2%-CREAM (ANTIFUNGAL) 20 289 GYNE LOTRIMIN SCHERING CLOTRIMAZOLE 01 29 93 COMBINATION PACK LIBERTY CORNER, NJ 100MG...
