Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019853
Company: VALEANT PHARMS INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CUPRIMINE PENICILLAMINE 250MG CAPSULE;ORAL Prescription AB Yes Yes
CUPRIMINE PENICILLAMINE 125MG CAPSULE;ORAL Discontinued None No No
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/26/2004 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf
10/26/2004 SUPPL-12 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19853s012,014lbl.pdf
05/27/2003 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19853slr013_cuprimine_lbl.pdf

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