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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/07/1992 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-28 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019891Orig1s028, 019892Orig1s035ltr.pdf
09/18/2018 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019891Orig1s026s027,019892Orig1s033s034Ltr.pdf
09/18/2018 SUPPL-26 REMS - PROPOSAL - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019891Orig1s026s027,019892Orig1s033s034Ltr.pdf
12/16/2016 SUPPL-24 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019891Orig1s024,019892Orig1s029ltr.pdf
02/05/2016 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/12/2016 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/12/2016 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/09/2015 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/16/2015 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/14/2013 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/12/2006 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019891s008, 019892s009LTR.pdf
08/22/2001 SUPPL-4 Labeling

Label is not available on this site.

11/24/1999 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/10/2003 SUPPL-2 Labeling

Label is not available on this site.

03/31/1995 SUPPL-1 Labeling

Label is not available on this site.

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

DILAUDID

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILAUDID HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription Yes AA 019891 RHODES PHARMS
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 210176 ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription No AA 074653 WEST-WARD PHARMS INT

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