Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019892
Company: RHODES PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DILAUDID HYDROMORPHONE HYDROCHLORIDE 8MG TABLET;ORAL Prescription AB Yes Yes
DILAUDID HYDROMORPHONE HYDROCHLORIDE 4MG TABLET;ORAL Prescription AB Yes No
DILAUDID HYDROMORPHONE HYDROCHLORIDE 2MG TABLET;ORAL Prescription AB Yes No
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-35 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-34 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-33 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-29 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
01/26/2015 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/05/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

12/18/2012 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/24/2013 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

11/09/2007 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019892s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019892s015ltr.pdf
06/12/2006 SUPPL-9 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
04/12/2001 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/2001 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/22/2001 SUPPL-4 Labeling

Label is not available on this site.

02/24/2000 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/10/2003 SUPPL-2 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19891slr002,19892slr002ltr.pdf
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-35 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf
10/07/2019 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf
09/18/2018 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf
09/18/2018 SUPPL-33 REMS - PROPOSAL - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf
12/16/2016 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf
12/16/2016 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf
11/09/2007 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019892s015lbl.pdf
06/12/2006 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.pdf

DILAUDID

TABLET;ORAL; 8MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILAUDID HYDROMORPHONE HYDROCHLORIDE 8MG TABLET;ORAL Prescription Yes AB 019892 RHODES PHARMS
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET;ORAL Prescription No AB 210506 ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET;ORAL Prescription No AB 205814 AUROLIFE PHARMA LLC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET;ORAL Prescription No AB 076723 ELITE LABS
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET;ORAL Prescription No AB 074597 HIKMA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET;ORAL Prescription No AB 077471 LANNETT CO INC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 8MG TABLET;ORAL Prescription No AB 076855 SPECGX LLC

TABLET;ORAL; 4MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILAUDID HYDROMORPHONE HYDROCHLORIDE 4MG TABLET;ORAL Prescription Yes AB 019892 RHODES PHARMS
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AB 210506 ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AB 205814 AUROLIFE PHARMA LLC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AB 074597 HIKMA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AB 078439 LANNETT
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AB 077471 LANNETT CO INC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 4MG TABLET;ORAL Prescription No AB 076855 SPECGX LLC

TABLET;ORAL; 2MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILAUDID HYDROMORPHONE HYDROCHLORIDE 2MG TABLET;ORAL Prescription Yes AB 019892 RHODES PHARMS
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG TABLET;ORAL Prescription No AB 210506 ASCENT PHARMS INC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG TABLET;ORAL Prescription No AB 205814 AUROLIFE PHARMA LLC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG TABLET;ORAL Prescription No AB 078439 LANNETT
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG TABLET;ORAL Prescription No AB 077471 LANNETT CO INC
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG TABLET;ORAL Prescription No AB 076855 SPECGX LLC

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