Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074597
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET;ORAL | Discontinued | None | No | No |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET;ORAL | Discontinued | None | 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)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/74597ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/074597.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/10/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/10/2020 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-15 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 05/29/2009 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 12/29/2006 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/09/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/25/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |