Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 216899
Company: HIKMA
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 |