http://www.fda.gov/cder/orange/appendix_a.txt IRRIGANT, NEOMYCIN SULFATE NEOSPORIN, BACITRACIN ZINC NEOSPORIN, GRAMICIDIN NEOSPORIN, NEOMYCIN SULFATE (OTC) NEOTHYLLINE, DYPHYLLINE NEOTRIZINE, TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE; SULFAMETHAZINE) NEPHRAMINE 5.4%, AMINO ACIDS NEPHROFLOW, IODOHIPPURATE SODIUM, I-123 NEPTAZANE, METHAZOLAMIDE NESACAINE, CHLOROPROCAINE HYDROCHLORIDE NESACAINE-MPF, CHLOROPROCAINE...
1998 Warning Letters and Untitled Letters to Pharmaceutical Companies DDMAC 6/25 6/29 Maxipime (Cefepime HCl) for Injection Bristol-Myers Squibb DDMAC 6/29 8/3 Mircette (Desogestrel/Ethinyl Estradiol and Ethinyl Estradiol) Tablets Organon DDMAC 6/1 6/9 Naprelan (Naproxen Sodium) Tablets Wyeth-Ayerst DDMAC 6/8 6/29 Nasacort (Triamcinolone Acetonide) Rhone-Poulenc Rorer DDMAC 6/25 6/29 Nasonex (mometasone furoate monohydrate) nasal...
http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt DIAZEPAM 1516 23-Apr-70 AVENTIS PHARMA SA CHLORPROMAZINE HYDROCHLORIDE 1534 01-Jun-70 PHARMACIA AND UPJOHN INC CYTARABINE AS MANUFACTURED IN KALAMAZOO MI 1535 11-Jun-70 PHARMACIA AND UPJOHN INC MEDRYSONE 1541 25-Jun-70 PHARMACIA AND UPJOHN INC FLUOROMETHOLONE MICRONIZED 1581 21-Sep-70 AVENTIS PHARMA SA CROMOLYN SODIUM AND CROMOLYN SODIUM/LACTOSE BLEND 1631 05-Jan-71 ADAMHA NIMH DELTA...
http://www.fda.gov/cder/dmf/xls/4Q2003ACTIVETYPE2EXCEL.xls DIAZEPAM AVENTIS PHARMA SA CHLORPROMAZINE HYDROCHLORIDE PHARMACIA AND UPJOHN INC CYTARABINE AS MANUFACTURED IN KALAMAZOO MI PHARMACIA AND UPJOHN INC MEDRYSONE PHARMACIA AND UPJOHN INC FLUOROMETHOLONE MICRONIZED AVENTIS PHARMA SA CROMOLYN SODIUM AND CROMOLYN SODIUM/LACTOSE BLEND ADAMHA NIMH DELTA-9-TRANS-TETRAHYDROCANNABINOL-DELTA-9-TRANS-TETRAHYDROCANNABINOL SSL INTERNATIONAL...
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> AB 800MG N74834 002 APR 24,...
author: AUTHOR
RLD_LABELING_ APPROVED_SEP_1999 Product Name Drug Name NDA No Supp.No Firm Date DOBUTAMINE Dobutamine In 5% Dextrose In Plastic 20-201 S-012 Abbott 01-Sep-1999 DEMULEN 1/35-21 Ethinyl Estradiol/Ethynodiol Diacetate Tablets 18-168 S-026 Searle 02-Sep-1999 DEMULEN 1/50-21 Ethynodiol Diacetate/Ethinyl Estradiol Tablets 16-927 S-062 Searle 02-Sep-1999 MIRAPEX Pramipexole Tablets 20-667 S-007...
PDPL - ADD - + ADV MAGNETICS EQ 11.2MG IRON/ML N20416 001 ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE - ADD - AUG 30, 1996 TABLET; ORAL-21 ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL 1/35-21 FLUPHENAZINE DECANOATE - DLT - AB WATSON LABS 0.035MG;1MG N72720 001 - DLT - DEC 30, 1991 INJECTABLE; INJECTION ETHYNODIOL DIACETATE AND ...
FDA Drug Approvals List August 1999 Application #:020547Efficacy Supplement#:007 Type: SE1 to Original New Drug Application Approval Date: 17-SEP-99 Trade Name: ACCOLATE Dosage Form: TABLET Applicant: ZENECA LTD Active Ingredient(s): ZAFIRLUKAST OTC/RX Status: RX Efficacy Claim: For the prophylaxis and chronic treatment of asthma in pdiatric patients 7-11 years of age Application #: 20711 Efficacy Supplement#: 003 Type...
THE MERCK MANUAL, Sec. 18, Ch. 246, Family Planning This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 18.ethinyl estradiol, and women taking formulations with 50 µg of estrogen should usually be switched to low-dose formulations.
THE MERCK MANUAL, Sec. 18, Ch. 246, Family Planning This Publication Is Searchable The Merck Manual of Diagnosis and Therapy--- Section 18ethinyl estradiol, and women taking formulations with 50 µg of estrogen should usually be switched to low-dose formulations
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.int-med.uiowa.edu/Intranet/Residents/xToDelete/GMedCurricOld/Jan-Jun%2004/Contraception/UTD-Oral.pdf Soon thereafter, ethinyl substitution of testosterone also was found to result in an orally active compound (ethisterone).Ethynodiol diacetate, another progestin in this category, ~Iso has significant estrogenic activity.ethynodiol diacetate, or a third- generation progestin (see "Ne ro...
author: floerchingerd [ M68498 ]
App49 Dr M. G. Davies Marketing Department Pharmacia Biotech (Biochrom) Limited Cambridge, England Introduction Standard methods for routine testing of materials are published by the Association of Official Analytical Chemists. AOAC methods are reliable because they have been collaboratively ...
author: lander
App49 page 2 SUMMARY OF ANALYTICAL METHODS RECOMMENDED INSTRUMENT NOVASPEC ll U 1000 U 2000 U 2000 + SWIFT U 3000 U 4000 COMMODITY ANALYSIS OUTLINE OF METHOD WAVELENGTHS nm Acetaminophen and salicylamide in drugs Ads column extract Etac. Etac/ CHCl3 210- 320, (248). 260- 370. (308) x x x Acetaminophen in drugs ...
author: lander
http://www.fda.gov/cder/ogd/rld/16927s62.pdf Frano: Please refer to your supplemental new drug applications dated July 22, 1998, received July 23, 1998, submitted under section 505( b) of the Federal Food, Drug, and Cosmetic Act for Demulen 1/ 50- 21, Demulen 1/ 50- 28 , Demulen 1/ 35- 21, Demulen 1/ 35- 28( ethynodiol diacetate and ethinyl estradiol) ethynodiol ...
http://www.fda.gov/cder/ogd/rld/16927s62.pdf page 15
http://www.fda.gov/cder/ogd/rld/16927s62.pdf page 3
http://www.fda.gov/cder/ogd/rld/16927s62.pdf page 1
Drug Approvals - D NDA 21-333 9/16/02 9/20/02 9/17/02 - Desogestrel & Ethinyl Estradiol Tablets, Rx Barr Laboratories ANDA 76-455 2/24/04 4/15/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively, Rx Tentatively Approved Duramed Pharmaceuticals ANDA 75-863 11/29/01 4/15/03 Desogestrel & Ethinyl Estradiol Tablets, 0.15 mg & 0.03, respectively...
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 SEP 10, 2003 DEC CTNA...
First-Time Generics - December 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search First-Time Generics - December 2002 - Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 AMANTADINE HYDROCHLORIDE TABLETS 100 MG UPSHER-SMITH LABORATORIES, INC
author: OGD
ANDA Approvals December 2002 Food and Drug Administration • Center for Drug Evaluation and Research Drug Information Search Approvals - December 2002 - ANDA- Number Generic Drug Name Applicant Approval Date 1 65-116 BACITRACIN FOR INJECTION, USP 50,000 UNITS/VIAL AMERICAN PHARMACEUTICAL PARTNERS, INC
author: OGD
Prescription and OTC Drug Product List 12/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACARBOSE TABLET; ORAL PRECOSE -D- BAYER 25MG N20482 004 MAY 29, 1997 DEC CAHN -D- 50MG N20482 001 SEP 06, 1995 DEC CAHN -D- + 100MG N20482 002 SEP 06, 1995 DEC CAHN -A- BAYER PHARMS 25MG N20482 004 MAY 29, 1997 DEC CAHN -A- 50MG N20482 001 SEP 06, 1995 DEC CAHN -A- + 100MG N20482 002 SEP 06, 1995 DEC CAHN ACYCLOVIR -A- CREAM;...
Prescription and OTC Drug Product List 9/2002 ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST -A- ADEFOVIR DIPIVOXIL -A- TABLET; ORAL -A- HEPSERA -A- + GILEAD 10MG N21449 001 SEP 20, 2002 SEP NEWA ALBUTEROL SULFATE TABLET, EXTENDED RELEASE; ORAL -A- ALBUTEROL SULFATE -A- AB SIDMAK LABS EQ 4MG BASE N76130 002 SEP 26, 2002 SEP NEWA -A- AB EQ 8MG BASE N76130 003 SEP 26, 2002 SEP NEWA VOLMAX -D- BC + MURO EQ 4MG BASE N19604...
FDA Drug Approvals List April 2000 Approvable Original New Drug Applications Original Abbreviated New Drug Applications Original Abbreviated Application # 074657 Approval Date: 28-APR-00 Trade Name: TERAZOSIN HCL Dosage Form: TABLET Applicant: INVAMED INC Active Ingredient(s): TERAZOSIN HYDROCHLORIDE OTC/RX Status: RX Original Abbreviated Antibiotic Application# 065041 Approval Date: 28-APR-00 Trade Name: DOXYCYCLINE...
