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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 ULTANE, SEVOFLURANE ...
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Prescription and OTC Drug Product List 11/1999
Prescription and Over-the-Counter Drug Product List - 19th Edition Cumulative Supplement Number 11: November 1999 [ Prescription - OTC ] - ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ALBUTEROL SULFATE BUPROPION HYDROCHLORIDE SOLUTION; INHALATION TABLET; ORAL ALBUTEROL SULFATE - ADD - BUPROPION HCL - ADD - AN MORTON GROVE EQ 0.083% BASE N75394 001 - ADD - AB TEVA...
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FDA Drug Approvals List October 1999
Application #: 020156 Efficacy Supplement#: 022 Type: SE2 to Original New Drug Application Approval Date: 28-OCT-99 Trade Name: VIDEX Dosage Form: POWDER, FOR RECONSTITUTION Applicant: BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE Active Ingredient(s): DIDANOSINE OTC/RX Status: RX Efficacy Claim:Provides for a new strength as well as allowing a change in dosing interval...
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FDA DRUG AND DEVICE PRODUCT APPROVALS
DEPARTMENT OF HEALTH AND HUMAN SERVICES, PUBLIC HEALTH SERVICE NDA NUMBER TRADE NAME APPLICANT ACTIVE INGREDIENT(S) APPROVAL DATE (DOSAGE FORM) STRENGTH(S) (CLASSIFICATION) CLASSIFICATION(S) ***ORIGINAL AND SUPPLEMENTAL NDAs*** FOR NEW DRUG PRODUCTS 19-898 PRAVACHOL BRISTOL MYERS SQUIBB PRAVASTATIN SODIUM 02-JUL-96 (TABLET) PRINCETON, NJ 10MG (SUPPL-015) 08543 20MG 40MG (NEW...
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July Drug Approvals
Drug Approvals for July 1996 Definitions and Notes Original New Drug Application Original Application #: 020538 Approval Date: 31-JUL-96 Trade Name: ESTRADIOL Chemical Type: Already marketed drug product but a new manufacturer Therapeutic Potential: Standard review drug Dosage Form: FILM, EXTENDED RELEASE Applicant: MENOREST MANFACTURING INC Active Ingredient(s): ESTRADIOL OTC/RX...
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http://www.fda.gov/cder/reports/cderfact.pdf page 21
author: Carolyn Spencer
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http://www.fda.gov/cder/reports/cderfact.pdf
pylori detection kit Manufacturer SmithKline Beecham Organon Lilly Pharmacia and Upjohn Boehringer Ingelheim Zeneca Gilead Glaxo Wellcome Hoechst Marion Roussel Parke Davis Enviroderm Advanced Magnetics Allergan Meretek Generic Name albendazole mirtazapine lispro irinotecan HCl nevirapine meropenen cidofovir remifentanil HCl fexofenadine HCl fosphenytion sodium bentoquatam...
author: Carolyn Spencer
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rld_labeling_approved_june_1999
Firm Date HIVID Zalcitabine tablets 20-199 S-013 Roche 01-Jun-1999 PROVENTIL-HFA Albuterol sulfate inhalation aerosol 20-503 S-011 3M Pharmaceuticals 02-Jun-1999 CRIXIVAN Indivir sulfate capsules 20-685 S-023 et al Merck Research 04-Jun-1999 VERALAN PM Verapamil HCl extended-release capsules 20-493 S-002 Elan Pharmaceutical 04-Jun-1999 DOPAMINE Dopamine HCl in 5% dextrose injection...
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RLD_LABELING_APPROVED_OCT_1999
Reference Listed Drug Labeling Approved in October 1999 Some of the product names below contain links to the approved labeling or the supplemental approval letter describing the specific changes.- Click on the product name to view the approved labeling changes in Adobe Acrobat format
Supp.No
19-011 S-013 Braintree Labs 7-Oct-1999 NuLYTELY PEG-3350,NaCl,NaHCO3,KCl for oral sol...
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45411_1542_CMDF_II_En_Debut page 35
author: Mac073
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45410_1530_CMDF_En_0_Debut page 37
author: Mac073
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http://www.fda.gov/cder/rdmt/escy99ap.htm
- - - - - - - - - - TERBINAFINE HYDROCHLORIDE NOVARTIS 20-980 03/30/98 03/09/99 N 0 N 11.3 Rx to OTC switch for the treatment of tinea pedis (athlete's foot), tinea cruris (jock itch) and tinea corporis (ringworm)
- - - - - - - - - - BUPROPION HYDROCHLORIDE GLAXO WELLCOME 20-711 08/05/97 09/10/99 SE4 1 N 25.2 For use as an aid to smoking cessation
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author: Darlene
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