Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019034
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 1MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 2MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 4MG/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 0.2MG/ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 0.5MG/0.5ML | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| DILAUDID-HP | HYDROMORPHONE HYDROCHLORIDE | 10MG/ML | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
| DILAUDID-HP | HYDROMORPHONE HYDROCHLORIDE | 250MG/VIAL | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 01/11/1984 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-46 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019034s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/019034Orig1s046ltr.pdf | |
| 01/16/2020 | SUPPL-37 |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019034s037lbl.pdf | ||
| 10/07/2019 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019034s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019034Orig1s035ltr.pdf | |
| 01/26/2018 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/10/2017 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019034s029lbl.pdf | |
| 12/16/2016 | SUPPL-27 | Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019034s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019034Orig1s027ltr.pdf | |
| 12/16/2016 | SUPPL-25 | Manufacturing (CMC)-Manufacturing Process |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019034Orig1s025ltr.pdf |
| 06/30/2011 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019034s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019034s021ltr.pdf | |
| 04/30/2009 | SUPPL-18 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019034s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019034s018ltr.pdf | |
| 06/12/2006 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019034s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019034s012LTR.pdf | |
| 11/09/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/18/2001 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/08/1994 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/04/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/16/1991 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/16/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/29/1984 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-46 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019034s046lbl.pdf | |
| 01/16/2020 | SUPPL-37 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019034s037lbl.pdf | |
| 10/07/2019 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019034s035lbl.pdf | |
| 02/10/2017 | SUPPL-29 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019034s029lbl.pdf | |
| 12/16/2016 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019034s027lbl.pdf | |
| 12/16/2016 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019034s027lbl.pdf | |
| 06/30/2011 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019034s021lbl.pdf | |
| 04/30/2009 | SUPPL-18 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019034s018lbl.pdf | |
| 06/12/2006 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019034s012lbl.pdf |
DILAUDID
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 |
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 |
DILAUDID-HP
There are no Therapeutic Equivalents.