http://www.fda.gov/cder/orange/appendix_a.txt 2, BUTABARBITAL SODIUM SARISOL, BUTABARBITAL SODIUM APPENDIX A PRODUCT NAME INDEX SATRIC, METRONIDAZOLE SCABENE, LINDANE SCANDONEST L, LEVONORDEFRIN SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE SCLEROSOL, TALC SCRUBTEAM SURGICAL SPONGEBRUSH, HEXACHLOROPHENE SEASONALE, ETHINYL ESTRADIOL SECOBARBITAL SODIUM, SECOBARBITAL SODIUM SECONAL SODIUM, SECOBARBITAL SODIUM SECREFLO,...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt KG "PROPAFENONE HYDROCHLORIDE MANUFACTURED IN RAUBLING, GERMANY" 10642 30-Dec-93 CIPLA LTD "ETOPOSIDE MANUFACTURED IN BANGALORE, INDIA" 10643 30-Dec-93 EURAND AMERICA INC "CAFFEINE MICROCAPS MANUFACTURED IN VANDALIA, OHIO" 10648 20-Dec-93 LONZA INC "TRIPROLIDINE HYDROCHLORIDE MANUFACTURED IN LOS ANGELES, CA" 10652 10-Jan-94 GADOR SA "ZOL EM HEMITARTRATE MANUFACTURED...
2003 Export Products List Alphabetical CHILDREN 2 TO 4 5760604342 ACET 120 Suppositories 12 YEARS OF AGE 5760604350 ACET 160 Suppositories 4 CHILDREN 2 TO 4 YEARS OF AGE 5760604352 ACET 160 Suppositories 12 5760604360 ACET 325 Suppositories 4 CHILDREN 4 TO 12 YEARS OF AGE 5760604362 ACET 325 Suppositories 12 5760604370 ACET 650 Suppositories 4 ADULTS 5760604372 ACET 650 Suppositories 12 5760660272 pms- Acetaminophen w/ ...
author: Lee S. Ehler
2003 Export Products List Alphabetical page 10
author: Lee S. Ehler
Export Products List by System July 2003 page 23
author: Lee S. Ehler
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...
Prescription and Over-the-Counter Drug Product List: 3/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL FIORICET W/ CODEINE -D- AB + NOVARTIS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN -A- AB + WATSON PHARMS 325MG;50MG;40MG;30MG N20232 001 JUL 30, 1992 MAR CAHN ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL CODRIX -A- +...
author: AUTHOR
FDA Drug Approvals List May 2001 Pylori eradication to reduce the risk of duodenal ulcer recurrence, maintenance of healed duodenal ulcers, short-term treatment of active benign gastric ulcer, short-term treatment of symptomatic gastroesophageal reflux disease (GERD), short-term treatment of erosive esophagitis, maintenance of healing of erosive esophagitis, and pathological hypersecretory conditions including...
FDA Drug Approvals List April 2002 - Drug Approvals for April 2002 Definitions and Notes Original New Drug Applications Original Application #: 021310 Approval Date: 05-APR-02 Trade Name: ALORA Chemical Type: 3 Therapeutic Potential: S Dosage Form: PATCH, CONTROLLED RELEASE Applicant: WATSON LABORATORIES INC Active Ingredient(s): ESTRADIOL OTC/RX Status: RX Indication(s): For the prevention of postmenopausal...
Prescription and OTC Drug Product List 8/2001 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST PRESCRIPTION DRUG PRODUCT LIST - 21ST EDITION ADDITIONS/DELETIONS FOR RX DRUG PRODUCT LIST - CUMULATIVE SUPPLEMENT 8 - AUG 2001 ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE CAPSULE; ORAL PHRENILIN WITH CAFFEINE AND CODEINE -A- AB AMARIN PHARMS 325MG;50MG;40MG;30MG N74911 001 AUG 22, 2001 AUG NEWA...
Prescription and OTC Drug Product List 11/1997 Prescription and Over-the-Counter Drug Product List - 17th Edition Cumulative Supplement Number 11: Jan '97 - Nov '97 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE AMANTADINE HYDROCHLORIDE TABLET; ORAL CAPSULE; ORAL PRECOSE - DLT - SYMADINE - DLT - BAYER 25MG N20482 004 - DLT - AB SOLVAY 100MG N71000 001 - DLT - MAY 29, 1997 - DLT - SEP...
DDPA April 1996 ***LABELING SUPPLEMENTS TO ORIGINAL NDAs*** 20-262 TAXOL BRISTOL MYERS SQUIBB PACLITAXEL 01-APR-96 (INJECTABLE) WALLINGFORD, CT 6MG/ML 06492 (LABELING REVISION -- BOXED WARNING; DESCRIPTION; WARNINGS; PRECAUTIONS; ADVERSE REACTIONS; DOSAGE AND ADMINISTRATION; HOW SUPPLIED) 18-602 CARDIZEM HOECHST MARION RSSL DILTIAZEM HYDROCHLORIDE 02-APR-96 (TABLET) KANSAS CITY, MO 30MG 64134...
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...
Allergy (m) Triprolidine hydrochlorideCodeine ingredientsCodeine Codeine phosphateCodeine sulfatePseudoephedrine hydrochloridePseudoephedrine sulfateC --Labeling Sec
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...
Paragraph IV Patent Certifications - DRUG NAME DOSAGE FORM STRENGTH RLD Acetaminophen Extended-release Tablets 650 mg Tylenol Acetaminophen/ Aspirin/ Caffeine Tablets 250 mg/250 mg/ 65 mg Excedrin (migraine) Acetaminophen and Tramadol Hydrochloride Tablets 325 mg/ 37.5 mg Ultracet Acyclovir Sodium1 Injection 50 mg/mL, 10 mL and 20 mL vials Zovirax Albuterol Sulfate Oral Syrup 2 mg(base)/ 5 mL Ventolin Albuterol...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls PROSINTEX SPA ALLOPURINOL UPJOHN MANUFACTURING CO MOTRIN TAB NOVUS FINE CHEMICALS, LLC PSEUDOEPHEDRINE HCL, SULFATE, AND BASE BULK POWDER TEVA PHARMACEUTICAL FINE CHEMICALS S.R.LPSEUDOEPHEDRINE HCL AS MANUFACTURED IN MINDEN, GERMANY NAPP CHEMICALS INC SILVER SULFADIAZINE CAMBREX PROFARMACO MILANO S.R.L
Prescription and Over-the-Counter Drug Product List: 11/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST >A> ABARELIX >A> INJECTABLE; INTRAMUSCULAR >A> PLENAXIS >A> + PRAECIS 100MG/VIAL N21320 001 NOV 25, 2003 NOV NEWA ALBUTEROL SULFATE SOLUTION; INHALATION ALBUTEROL SULFATE >A> AN BREATH LTD EQ 0.083% BASE N76370 001 NOV 24, 2003 NOV NEWA BACLOFEN TABLET, ORALLY DISINTEGRATING; ORAL KEMSTRO >D> SCHWARZ PHARMA 10MG N21589 001 OCT 30...
ANDA Approvals January 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - January 2003 - ANDA Number- Generic Drug Name Applicant Approval Date 1 40-474 HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP 7.5 MG/650 MG ABLE LABORATORIES, INCHYDROCHLORIDE INJECTION, USP 20 MG/ML (400 MG/20 ML) MULTIPLE- DOSE...
author: OGD
ANDA Approvals February 2003 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - February 2003 - ANDA Number Generic Drug Name Applicant Approval Date 1 76-028 VINORELBINE TARTRATE INJECTION 10 MG (BASE)/ML; PACKAGED IN 10 MG/ML AND 50 MG/5 ML SINGLE-DOSE VIALS GENSIA SICOR PHARMACEUTICALS, INCHYDROCHLORIDE JELLY,...
author: OGD
Prescription and Over-the-Counter Drug Product List: 2/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL -A- CODRIX -A- + ANDRX PHARMS 500MG;15MG N40447 001 FEB 26, 2003 FEB NEWA AZATHIOPRINE TABLET; ORAL AZASAN -A- AAIPHARMA LLC 25MG N75252 002 FEB 03, 2003 FEB NEWA -A- AB 50MG N75252 001 JUN 07, 1999 FEB NEWA -A- 75MG N75252 003 FEB 03, 2003 FEB NEWA -A- 100MG N75252 004...
author: AUTHOR
Prescription and Over-the-Counter Drug Product List: 1/2003 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; BUTALBITAL; CAFFEINE -A- SOLUTION; ORAL -A- ACETAMINOPHEN AND BUTALBITAL AND CAFFEINE -A- + MIKART 325MG/15ML;50MG/15ML;40MG/15ML N40387 001 JAN 31, 2003 JAN NEWA ACETAMINOPHEN; CODEINE PHOSPHATE TABLET; ORAL ACETAMINOPHEN AND CODEINE PHOSPAHTE -A- AA ANDRX PHARMS 300MG;15MG N40443 001 JAN 22,...
author: AUTHOR
FDA Drug Approvals List March 2001 Original Application #: 021082 Approval Date: 01-MAR-01 Trade Name: TAVIST ALLERGY/SINUS/HEADACHE Chemical Type: 4 Therapeutic Potential: S Dosage Form: TABLET Applicant: NOVARTIS CONSUMER HEALTH INC Active Ingredient(s): ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE OTC/RX Status: OTC Indication(s): For temporary relief of symptoms associated with hay...
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 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...
