Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074653
Company: HIKMA
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 |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Prescription | No | AA | 207108 | LANNETT CO INC |
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