Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074653
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 5MG/5ML SOLUTION;ORAL Prescription AA No 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
07/29/1998 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74653ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/10/2020 SUPPL-14 Labeling-Package Insert

Label is not available on this site.
04/10/2020 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
09/18/2018 SUPPL-9 REMS - PROPOSAL - D-N-A

Label is not available on this site.
10/18/1999 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
05/11/1999 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

HYDROMORPHONE HYDROCHLORIDE

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 HIKMA

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