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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216899
Company: HIKMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription AP No No
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE;INJECTION Prescription AP No No
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription AP No No
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription AP 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
02/09/2024 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216899Orig1s000ltr.pdf

HYDROMORPHONE HYDROCHLORIDE

INJECTABLE;INJECTION; 0.2MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILAUDID HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription Yes AP 019034 FRESENIUS KABI USA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 0.2MG/ML INJECTABLE;INJECTION Prescription No AP 216899 HIKMA

INJECTABLE;INJECTION; 0.5MG/0.5ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILAUDID HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE;INJECTION Prescription Yes AP 019034 FRESENIUS KABI USA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 0.5MG/0.5ML INJECTABLE;INJECTION Prescription No AP 216899 HIKMA

INJECTABLE;INJECTION; 1MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILAUDID HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription Yes AP 019034 FRESENIUS KABI USA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 216899 HIKMA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 1MG/ML INJECTABLE;INJECTION Prescription No AP 200403 HOSPIRA INC

INJECTABLE;INJECTION; 2MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DILAUDID HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription Yes AP 019034 FRESENIUS KABI USA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 202159 HIKMA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 216899 HIKMA
HYDROMORPHONE HYDROCHLORIDE HYDROMORPHONE HYDROCHLORIDE 2MG/ML INJECTABLE;INJECTION Prescription No AP 200403 HOSPIRA INC
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