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Documents 1-12 out of 12 found
  Current Search:  erypar: 2, erythromycin: 3104, stearate: 300  
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http://www.fda.gov/cder/orange/appendix_a.txt
400, ERYTHROMYCIN ETHYLSUCCINATE E.E.S., ERYTHROMYCIN ETHYLSUCCINATE EC-NAPROSYN, NAPROXEN ECONAZOLE NITRATE, ECONAZOLE NITRATE ECONOCHLOR, CHLORAMPHENICOL ECONOPRED PLUS, PREDNISOLONE ACETATE ECONOPRED, PREDNISOLONE ACETATE EDECRIN, ETHACRYNATE SODIUM EDECRIN, ETHACRYNIC ACID EDETATE DISODIUM, EDETATE DISODIUM EDEX, ALPROSTADIL EDROPHONIUM CHLORIDE PRESERVATIVE FREE,...

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http://www.fda.gov/cder/dmf/text/4Q2003ACTIVETYPE2TEXT.txt
OF IRELAND" 13266 05-Oct-98 FABBRICA ITALIANA SINTETICI SPA "NITROFURANTOIN MONHYDRATE, MANUFACTURED IN VICENZA, ITALY" 13277 22-Oct-98 MATRIX LABORATORIES LIMITED "ACYCLOVIR USP, MANUFACTURED IN ANDHRA PRADESH, INDIA" 13279 19-Oct-98 SYLACHIM DIV FINORGA "LEVOBETAXOLOL HYDROCHLORIDE, MANUFACTURED IN CHASSE-SUR-RHONE, FRANCE" 13282 15-Oct-98 DAICEL CHEMICAL INDUSTRIES LTD "CHIRALPAK...

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PDF
http://www.fda.gov/cder/foi/label/2001/18821s20lbl.pdf
Reglan ® Tablets (Metocloprami e Tablets, USP) Reglan ® S rup (Metocloprami e Oral Solution, USP) Reglan ® Injectable (Metocloprami e Injection, USP) CI 601 only DESCRIPTION For oral a ministration, Reglan Tablets ( Metocloprami e Tablets, USP) 10 mg are white, score , capsule- shape engrave on one si e an 10 on the opposite si e
Each tablet contains: Metocloprami e...

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V:\DAVDP\CSO\SILLIVAN\NDA\N20636\S016Aplet.doc
NDA 20- 636 NDA 20- 933 Page 3 Viramune ® (nevirapine) Tablets Viramune ® (nevirapine) Oral Suspension Rx only WARNING Severe, life- threatening, and in some cases fatal hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure, has been reported in patients treated with VIRAMUNE
EACH TABLET CONTAINS 200 MG OF NEVIRAPINE AND THE...

author: Tony DeCicco
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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
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Prescription and OTC Drug Product List 5/2001
Prescription and Over-the-Counter Drug Product List - 21st Edition Cumulative Supplement Number 5: January-May 2001 [ Prescription - OTC ] ADDITIONS/DELETIONS FOR PRESCRIPTION DRUG PRODUCT LIST ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE - ADD - ALMOTRIPTAN MALATE CAPSULE; ORAL - ADD - TABLET; ORAL ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE - ADD - AXERT - DLT - + MIKART 150MG;180MG...
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Erythromycin - Erythromycin Thiocyante - Erythromycin Stearate (1)
Summary Report The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology Unit 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8447 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html EMEA ...

author: MRL subject: Summary Report
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Erythromycin - Erythromycin Thiocyante - Erythromycin Stearate (1) page 4
Summary Report 4/ 4 EMEA 2000 LIST OF QUESTIONS Before the 01.06.1999, the following information is requested. 1. The applicant should provide information about the name and the structures of the impurities and complete the criteria of solubility of erythromycin salts in solvents. 2. The applicant should propose ...

author: MRL subject: Summary Report
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Erythromycin - Erythromycin Thiocyante - Erythromycin Stearate (1) page 3
Summary Report 3/ 4 EMEA 2000 18. As there is no available (physicochemical) analytical method validated according to the recommendations of Volume VI of the Rules Govering Medicinal Products in the European Community; the following MRLs based on all active antimicrobial residues should be proposed as provisional ...

author: MRL subject: Summary Report
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Erythromycin - Erythromycin Thiocyante - Erythromycin Stearate (1) page 2
Summary Report 2/ 4 EMEA 2000 9. In a reproduction study, two groups of 21 rats received 21 ppm of erythromycin thiocyanate in feed during 100 days before mating. Females of parent generation (FO) were mated three times, and female offspring of these three matings were followed through three subsequent generations ...

author: MRL subject: Summary Report
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Erythromycin - Erythromycin Thiocyante - Erythromycin Stearate (1) page 1
Summary Report The European Agency for the Evaluation of Medicinal Products Veterinary Medicines and Information Technology Unit 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Switchboard: (+ 44- 171) 418 8400 Fax: (+ 44- 171) 418 8447 E_ Mail: mail@ emea. eudra. org http:// www. eudra. org/ emea. html EMEA ...

author: MRL subject: Summary Report
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Celexa Approval
1 ATTACHMENT FINAL LABELING Celexa TM (citalopram hydrobromide) DESCRIPTION Celexa (citalopram HBr) is an orally administered selective serotonin reuptake inhibitor (SSRI) TM with a chemical structure unrelated to that of other SSRI's or of tricyclic, tetracyclic, or other available antidepressant agents
No adjustment of dosage for such patients is recommended
All patients with...

author: Paul David subject: Package Labeling
duplicates:
http://www.fda.gov/cder/foi/label/1998/20822lbl.pdf
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