http://www.fda.gov/cder/orange/appendix_a.txt
4, ACETAMINOPHEN TYLENOL W/ CODEINE, ACETAMINOPHEN TYLENOL, ACETAMINOPHEN (OTC) TYLOX, ACETAMINOPHEN TYLOX-325, ACETAMINOPHEN TYMTRAN, CERULETIDE DIETHYLAMINE TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE TZ-3, TIOCONAZOLE (OTC) ** U ** U-CORT, HYDROCORTISONE ACETATE U-GENCIN, GENTAMICIN SULFATE UCEPHAN, SODIUM BENZOATE ULO, CHLOPHEDIANOL HYDROCHLORIDE ...
Prescription and OTC Drug Product List 12/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE CAPSULE; ORAL SYNALGOS-DC-A -A- @ WOMEN FIRST HLTHCARE 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN -D- @ WYETH AYERST 356.4MG;30MG;16MG N89166 001 MAY 14, 1986 DEC CAHN ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL ANEXSIA 5/325 -D- AA MALLINCKRODT 325MG...
srx10b0.tmp
The Division of Bioequivalence has determined your Propoxyphene Hydrochloride and Acetaminophen Tablets USP, 65 mg/ 650 mg to be bioequivalent and, therefore, therapeutically equivalent to the listed drug Wygesic@ Tablets, 65 mg/ 650 mg of Wyeth Ayerst Laboratories Inc The firm revised their Stability Protocol, the Finished Product test method, and...
author: fda
srx10b0.tmp page 2
author: fda
srx10b0.tmp page 4
author: fda
Prescription and Over-the-Counter Drug Product List: 12/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE >A> + MIKART 750MG;50MG;40MG N40496 001 DEC 23, 2003 DEC NEWA ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE TABLET; ORAL DARVOCET A500 >D> + AAIPHARMA 500MG;100MG N76429 001 SEP 10, 2003 DEC CTNA >A> + 500MG;100MG N76429 001...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
IN BUDAPEST, HUNGARY" 1906 08-Mar-72 PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE 1913 05-Apr-72 LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE 1949 09-Jun-72 AVENTIS PHARMA SA PROMETHAZINE HCL 1976 24-Jul-72 GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK 1985 16-Aug-72 SCHERING AG ETHINYL ESTRADIOL 2030 18-Dec-72 ROCHE COLORADO...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls
IN BUDAPEST, HUNGARY PLANTEX LTD CHEM AND PHARM WORKS IMIPRAMINE HYDROCHLORIDE LUNDBECK PHARMACEUTICALS ITALY SPA IMIPRAMINE HYDROCHLORIDE AVENTIS PHARMA SA PROMETHAZINE HCL GRUPPO LEPETIT SPA D-PROPOXYPHENE HYDROCHLORIDE BULK SCHERING AG ETHINYL ESTRADIOL ROCHE COLORADO CORPORATION 3M PHARMS CORDRAN (FLURANDRENOLIDE) TAPE ORGANICS DIV LA GRANGE INC...
OGD Suitability Tracking Reports (Sorted by Petition Number) as of 1/5/2004
- TABLET; ORAL Approved 2/28/2003- BACLOFEN 10 mg, 20 mg - 02P-0078/CP1 KLEINFELD, KAPLAN & BECKER - ORALLY DISINTEGRATING TABLETS Approved 2/5/2003- OXYCODONE 5mg, 7.5mg, 10mg ACETAMINOPHEN 300mg - 02P-0105/CP1 LACHMAN CONSULTANT SERVICES - TABLETS Approved 8/6/2002- CARISOPRODOL 350 mg - 02P-0138/CP1 LACHMAN CONSULTANT SERVICES - ORALLY DISINTEGRATING TABLETS Withdrawn 7/25...
OGD Suitability Tracking Reports (Sorted by Drug Name) as of 1/5/2004
- TABLET; ORAL, CAPSULE;ORAL Approved 4/14/2000- ACETAMINOPHEN 770 MG, 385 MG CAFFEINE 60 MG, 30 MG - 03P-0505/CP1 LACHMAN CONSULTANT SERVICES - TABLET Approved - ACETAMINOPHEN; 320 MG/10 ML HYDROCODONE BITARTRATE 10 MG/10 ML - 01P-0130/CP2 PHARMACEUTICAL ASSOCIATES, INC - SOLUTION; ORAL Denied 7/9/2002- ACETAMINOPHEN; 325 MG & 500MG/15 ML HYDROCODONE BITARTRATE 10...
ANDA Approvals - September 2003
9/5/2003- 7 40-535 OXYCODONE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/325 MG AND 10 MG/325 MG - WATSON LABORATORIES, INC 9/10/2003- 12 76-429 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/500 MG - AAI PHARMA 9/10/2003- 13 76-577 MIDODRINE HYDROCHLORIDE TABLETS 2.5 MG, 5 MG, AND 10 MG - MYLAN PHARMACEUTICALS, INC 9/16/2003- 21 76-409...
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...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 8/2003
4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.4MG/HR N74607 001 AUG 30, 1996 AUG CRLD >D> AB2 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >A> AB2 + 0.6MG/HR N74559 001 AUG 30, 1996 AUG CRLD >D> TRANSDERM-NITRO >D> AB2 + NOVARTIS 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >A> @ 0.1MG/HR N20144 001 FEB 27, 1996 AUG DISC >D> AB2 + 0.2MG/HR N20144 002 FEB 27, 1996 AUG DISC >A> @ 0.2MG...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 7/2003
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE TABLET; ORAL PROPOXYPHENE HCL AND ACETAMINOPHEN >A> AA VINTAGE PHARMS 650MG;65MG N40507 001 JUL 30, 2003 JUL NEWA ACYCLOVIR TABLET; ORAL ACYCLOVIR >D> AB CLONMEL HLTHCARE 400MG N74834 001 APR 24, 1997 JUL DISC >A> @ 400MG N74834 001 APR 24, 1997 JUL DISC >D>...
author: AUTHOR
1997 Abbreviated New Drug Applications (Generic Drugs)
040109 8/26/1997 4/27/1998 Acetaminophen -Codeine Phosphate Purepac Pharmaceutical 086683 -05/11/1979 8/4/2003 Acetaminophen -Codeine Phosphate Purepac Pharmaceutical 086681 -05/11/1979 8/4/2003 Acetazolamide Tablets USP, 125 mg and 250 mg 040099 6/25/1997 3/27/1998 Hydrocodone Bitartrate and Acetaminophen Tablets 5mg/500 mg and 7.5 mg/750 mg [1.2 MB] Halsey Drug...
ANDA Approvals February 2001
Food and Drug Administration Center for Drug Evaluation and Research Drug Information Approvals February 2001 ANDA NUMBER DRUG- NAME APPLICANT APPROVAL DATE 1 65-061 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP 150 MG (BASE)------- 300 MG (BASE) RANBAXY LABORATORIES LIMITED 2/2/01 2 75-738 PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS, USP 100 MG/650 MG...
author: USERNAME
FDA Drug Approvals List July 2001
- Drug Approvals for July 2001 Definitions and Notes Original New Drug Applications Original Application #: 021064 Approval Date: 31-JUL-01 Trade Name: DEFINITY Chemical Type: 1 Therapeutic Potential: S Dosage Form: INJECTION Applicant: DUPONT PHARMACEUTICALS CO Active Ingredient(s): PERFLUTREN LI MICROSPHERE OTC/RX Status: RX Indication(s): For the treatment patients with suboptimal...
FDA Drug Approvals List February 2001
Approvable Original New Drug Applications - Original Abbreviated New Drug Applications Original Abbreviated Application # 075402 Approval Date: 28-FEB-01 Trade Name: METAPROTERENOL SULFATE Dosage Form: SOLUTION Applicant: NOVEX PHARMA Active Ingredient(s): METAPROTERENOL SULFATE OTC/RX Status: RX Original Abbreviated Application # 075403 Approval Date: 28-FEB-01 Trade Name:...
Prescription and OTC Drug Product List 7/2001
ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE TABLET; ORAL BUTALBITAL, ACETAMINOPHEN AND CAFFEINE -A- AB ABLE 325MG;50MG;40MG N40390 001 JUL 23, 2001 JUL NEWA -A- AB 500MG;50MG;40MG N40394 001 JUL 23, 2001 JUL NEWA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN -D- AA +...
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...
EVALUATION OF THE NEW YORK STATE ONECARD RX WORKERS COMPENSATION BENEFIT page 77
author: Julia Graffam
duplicates:http://www.quintiles.com/NR/rdonlyres/esnb6djlmpmd267ms6votav3bmvxowbn6p7p3tdm3hpo33qoowyjxa2dtx6ssx4tapmrkojnqv3rxjukkkphpf33g6c/1503.pdf
EVALUATION OF THE NEW YORK STATE ONECARD RX WORKERS COMPENSATION BENEFIT page 72
author: Julia Graffam
duplicates:http://www.quintiles.com/NR/rdonlyres/esnb6djlmpmd267ms6votav3bmvxowbn6p7p3tdm3hpo33qoowyjxa2dtx6ssx4tapmrkojnqv3rxjukkkphpf33g6c/1503.pdf
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
ranbaxy
- - - - - - You are here :- Home - Products - - Dosage Forms - INDIA DOSAGE FORMS LIST- (Updated Jan 2002) Anti-infectives G.I. & Nutritionals CVS & Diabetes CNS NSAID & related Anti-allergants ...
http://www.medvet.com.au/downloads/drg_scr/sitescreen_product_insert.pdf
M e t h a d o n e: Methadone is a synthetic analgesic drug that is originally used in the treatment of narcotic addicts. Among the psychological effects induced by using methadone are analgesia, sedation and respiratory depression. Overdose of methadone may cause coma or even death. It is administered ...