Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019891
Company: RHODES PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILAUDID HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription AA Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-28 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf
10/07/2019 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf
09/18/2018 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf
09/18/2018 SUPPL-26 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf
12/16/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf
12/16/2016 SUPPL-24 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf
06/12/2006 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.pdf

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