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,...
50687S4_Banan.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Banan (Cefpodoxime Proxetil) Tablets & Granules for Oral Suspension- Company:- Sankyo Pharma Inc
author: Paul Stauffer
FDA Drug Approvals List February 2000 - Drug Approvals for February 2000 Definitions and Notes Original New Drug Applications Original Application #: 021015 Approval Date: 28-FEB-00 Trade Name: ANDROGEL Chemical Type: 3 Therapeutic Potential: S Dosage Form: GEL Applicant: UNIMED PHARMACEUTICALS INC Active Ingredient(s): TESTOSTERONE OTC/RX Status: RX Indication(s): For replacement therapy in males for conditions...
FDA Drug Approvals List- May 1999 Efficacy Supplemental New Drug Applications Application #: 020584 Efficacy Supplement#: 003 Type: SE2 to Original New Drug Application Approval Date: 27-MAY-99 Trade Name: LODINE XL Dosage Form: TABLET, EXTENDED RELEASE Applicant: WYETH AYERST LABORATORIES INC Active Ingredient(s): ETODOLAC OTC/RX Status: RX Efficacy Claim: For the management of the signs and symptoms of...
DDPA June 1995 74-423 CAPTOPRIL MOVA CAPTOPRIL 07-JUN-95 (TABLET) CAGUAS, PR 12.5MG 00725 25MG 50MG 100MG (ANGIOTENSIN CONVERTING ENZYME INHIBITOR) ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 17-911 CLINORIL MERCK SULINDAC 01-JUN-95 (TABLET) WEST POINT, PA 150MG 19486 200MG (LABELING REVISION -- PRECAUTIONS; ADVERSE REACTIONS) 16-744* NORIDAY 1+50-FE SYNTEX FERROUS FUMARATE 02-JUN-95 (TABLET) PALO...
Drug Approvals for December 1997 Active Ingredient(s): EMEDASTINE DIFUMARATE OTC/RX Status: RX Indication(s): For the temporary relief of the signs and symptoms of allergic conjunctivitis Original Application #: 020786 Approval Date: 24-DEC-97 Trade Name: ALLEGRA-D Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET, EXTENDED RELEASE Applicant: HOECHST MARION ROUSSEL, INC Active Ingredient(s): FEXOFENADINE...
http://www.biosis.org/ts/media/cdjournals/gazettenews/2002/CPG_News_0243.pdf week 0243 25 October 2002 Wyeth has nine applications claiming bi- and tricyclic (di)azepine carboxamides as oxytocin/vasopressin antagonists, continuing the seires from which WAY-VNA-932 has been selected for preclinical studies (see page 21) ISSN:1464-3499 Drug Patenting in Context US authorities to market its 10 mg and 20 mg omeprazole capsules.
Gazette Highlights News 2002 - Thomson Scientific Thomson.com - - - - - Advanced Search - - - EN : JP : CN : KR -- - - Thomson Scientific : Gazette Weekly Highlights News : Gazette Highlights News 2002 - Gazette Highlights News 2002 Click on a week to view more Week 52: We wish all readers a happy and successful New Year!
Maximum Recommended Therapeutic Dose (MRTD) Database Maximum Recommended Therapeutic Dose (MRTD) Database (1,235 pharmaceuticals) A -- B- - C -- D -- E -- F-G -- H-K -- L -- M -- N -- O -- P -- Q-R -- S -- T -- U-Z MRTD--- (mg/kg--- bw/day) -- Generic Chemical Name Chemical Structure (SMILES Code) 3.00000-- Acemetacin C1=C(OC)C=C3C(=C1)N(C(=O)C2=CC=C(Cl)C=C2)C(C)=C3CC(=O)OCC(O)=O 0.20000-- Acenocoumarol C1=CC=C3C(=C1)OC(=O)C(C(CC(C)=O...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt "DEXRAZOXANE AS MFG IN PETERSBURG,VA." 15187 07-Dec-00 CHEMAGIS LTD "MOMETASONE FUROATE AS MFG IN BE'ER SHEVA,ISRAEL" 15191 15-Dec-00 LECIVA AS "TETRAHYDROZOLINE HYDROCHLORIDE USP,AS MFG IN PRAHA,CZECH REPUBLIC." 15192 18-Dec-00 RANBAXY LABORATORIES LTD "CEFPODOXIME PROXETIL AS MFG IN PUNJAB,INDIA" 15193 19-Dec-00 API CORPORATION "MYCOPHENOLIC ACID, TECHNICAL GRADE ...
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 7/25/2002-...
OGD Suitability Tracking Reports (Sorted by Drug Name) 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 Drug Name) as of 1/5/2004 Drug/Strength Petition No/Firm Dosage Form Status Status Date ACETAMINOPHEN 200MG;200MG; 200MG HYDROCODONE BITARTRATE 5MG;7.5MG;10MG - 02P-0004/CP1 SHOTWELL AND CARR, INC
Prescription and Over-the-Counter Drug Product List: 8/2003 4 >D> AA + ORTHO MCNEIL PHARM 300MG;60MG N85055 004 AUG DISC >A> @ 300MG;60MG N85055 004 AUG DISC ACETAMINOPHEN; HYDROCODONE BITARTRATE SOLUTION; ORAL HYDROCODONE BITARTRATE AND ACETAMINOPHEN >A> AA + MALLINCKRODT 500MG/15ML;10MG/15ML N40508 001 AUG 29, 2003 AUG NEWA >D> MIKART 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG CTEC >A> AA 500MG/15ML;5MG/15ML N81226 001 OCT 27, 1992 AUG...
author: AUTHOR
ANDA Approvals - August 2003 - FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER - Search - -Approvals - August 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 65-080 AMOXICILLIN TABLETS FOR ORAL SUSPENSION 200 MG AND 400 MG - RANBAXY LABORATORIES LIMITED 8/11/2003- 2 76-134 LORATADINE TABLETS (OTC) 10 MG - RANBAXY LABORATORIES LIMITED 8/18/2003- 3 76-453 LIDOCAINE...
OGD, First Time Approvals - May 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - May 2002 Generic Drug Name Generic Manufacturer Brand Name Approval Date 1- IDARUBICIN HYDROCHLORIDE FOR INJECTION, USP 5 MG, 10 MG, AND 20 MG SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INC
author: OGD
ANDA Approvals May 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - May 2002 - ANDA Number Drug Name Applicant Approval Date 1 65-036 IDARUBICIN HYDROCHLORIDE INJECTION 1 MG/ML; (5 MG/5 ML, 10 MG/10 ML, AND 20 MG/20 ML SINGLE-DOSE VIALS) GENSIA SICOR PHARMACEUTICALS, INC
author: OGD
50675S14_Vantin.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Vantin (Cefpodoxime Proxetil) Oral Suspension Company:- Pharmacia & Upjohn Application No.:- 50-675/S014 Approval Date:-11/20/1998 - Approval Letter(s) - Medical Review(s)- - Part 1 - Part 2 - Statistical Review(s) Microbiology Review(s) - Clinical Pharmacology...
author: Paul Stauffer
Efficacy Supplements Approved in Calendar Year 1998 EFFICACY SUPPLEMENTS APPROVED IN CY 98 GENERIC NAME APPLICANT NDA NUMBER RECEIPT DATE APPROVAL DATE SUPPLEMENT TYPE TOTAL APPROVAL TIME (MONTHS) INDICATION/DESCRIPTION ACARBOSE BAYER 20-482 30-Sep-97 29-Sep-98 SE1 12.0 For patients with type 2 diabetes treated with diet plus insulinCEFPODOXIME PROXETIL PHARMACIA AND UPJOHN 50-674 22-Jan-98 20-Nov-98 SE1 9.9 Treatment...
author: Brenda Harmon
http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_NOV_1998.HTML Firm Date PHENDIMETRAZINE TARTRATE CAPSULE Phendimetrazine Tartrate Capsule 18-074 S-028 Eon 3-Nov-1998 BUTISOL SODIUM Butabarbital Sodium Tablet 00-793 S-015 Wallace 4-Nov-1998 HYDRODIURIL Hydrochlorothiazide Tablet 11-835 S-060 Merck 5-Nov-1998 ATROVENT MDI Ipratropium Bromide 20-394 S-001 Boehringer-Ingelheim 9-Nov-1998 PEPCID AC Famotidine Tablet 20-325 S-007 Merck 9-Nov-1998...
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...
Prescription and OTC Drug Product List 5/2002 2 -D- + ROBINS AH 325MG;15MG N84444 001 MAY DISC -A- @ 325MG;15MG N84444 001 MAY DISC SOLUTION; ORAL ACETAMINOPHEN AND CODEINE PHOSPHATE -D- AA ALPHARMA 120MG/5ML;12MG/5ML N85861 001 MAY CRLD -A- AA + 120MG/5ML;12MG/5ML N85861 001 MAY CRLD TYLENOL W/ CODEINE -D- AA + JOHNSON RW 120MG/5ML;12MG/5ML N85057 001 MAY DISC -A- @ 120MG/5ML;12MG/5ML N85057 001 MAY DISC TABLET; ORAL...
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author: Les
ranbaxy - -- - - - You are here :- Home - News Room - - Press Releases Press Releases - Choose Year : -- Press Releases for the year 2002 December 2002 DaY : 10 RANBAXY TO LAUNCH GENERIC CO-AMOXYCLAV IN THE US MARKET ...
ranbaxy - - - - -- You are here :- Home - News Room - June 2002 Ranbaxy receives US FDA approval for the Manufacturing and Marketing of Cefpodoxime Proxetil Suspension New Delhi, June 04, 2002 Ranbaxy Pharmaceuticals ...
ranbaxy - -- - - - - You are here :- Home - News Room - - Press Releases Press Releases January 2001 RANBAXY ANNUAL GLOBAL SALES CROSS US $500 MILLION, JAN.15,2001 Ranbaxy's US operations, wholly owned ...
