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chgj2000
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[交流]
【求助】求申報資料
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| Feridex能幫我查下它的申報資料嗎(FDA) |
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Drug Details Drug Name(s) FERIDEX I.V. (Brand Name Drug) FDA Application No. (NDA) 020416 Active Ingredient(s) FERUMOXIDES Company AMAG PHARMS INC Original Approval or Tentative Approval Date August 30, 1996 Chemical Type 1 New molecular entity (NME) Review Classification S Standard review drug There are no Therapeutic Equivalents Labels are not available Approval History, Letters, Reviews, and Related Documents Products on Application (NDA) #020416 Click on a column header to re-sort the table: Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code FERIDEX I.V. FERUMOXIDES EQ 11.2MG IRON/ML INJECTABLE; INJECTION Prescription Yes None 這個藥沒有說明書! Label Information What information does a label include? Note: Not all labels are available in electronic format from FDA. Labels are not available on this site for FERIDEX I.V., NDA no. 020416 Approval History NDA 020416 Note: Not all reviews are available in electronic format from FDA. Older labels are for historical information only, and should not be used for clinical purposes. Approval dates can only be verified from 1984 to the present. Click on a column header to re-sort the table: Action Date Supplement Number Approval Type Letters, Reviews, Labels, Patient Package Insert Note 10/11/1996 001 Labeling Revision Label is not available on this site. 08/30/1996 000 Approval Label is not available on this site. Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players There are no Therapeutic Equivalents |
銅蟲 (小有名氣)
至尊木蟲 (著名寫手)
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http://www.amagpharma.com/products/feridex_iv.php In November 2008, the Company ceased manufacturing of Feridex and does not intend to continue its commercialization. The Company has terminated agreements with all of our Feridex marketing partners including Bayer Healthcare Pharmaceuticals and TaeJoon Pharmaceuticals Co., Ltd. 人家都不賣了啊。 |
銅蟲 (小有名氣)
木蟲 (著名寫手)
銅蟲 (小有名氣)
銅蟲 (小有名氣)
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