Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 210176
Company: ASCENT PHARMS INC
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
10/27/2017 ORIG-1 Approval 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
09/18/2018 SUPPL-2 REMS - PROPOSAL - D-N-A

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 WEST-WARD PHARMS INT

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