Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204278
Company: PADAGIS US
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | No | No |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 04/06/2015 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204278Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/15/2023 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/22/2023 | SUPPL-17 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/26/2021 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/26/2021 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-12 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-11 | REMS-Modified |
Label is not available on this site. |
||
| 02/17/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/30/2016 | SUPPL-6 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/20/2016 | SUPPL-3 | REMS-Modified |
Label is not available on this site. |
||
| 10/20/2017 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/26/2015 | SUPPL-1 | REMS-Proposal |
Label is not available on this site. |
HYDROMORPHONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 8MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212133 | ASCENT PHARMS INC |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205629 | OSMOTICA PHARM US |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204278 | PADAGIS US |
TABLET, EXTENDED RELEASE;ORAL; 12MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212133 | ASCENT PHARMS INC |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205629 | OSMOTICA PHARM US |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 12MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204278 | PADAGIS US |
TABLET, EXTENDED RELEASE;ORAL; 16MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212133 | ASCENT PHARMS INC |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205629 | OSMOTICA PHARM US |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 16MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204278 | PADAGIS US |
TABLET, EXTENDED RELEASE;ORAL; 32MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 212133 | ASCENT PHARMS INC |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 205629 | OSMOTICA PHARM US |
| HYDROMORPHONE HYDROCHLORIDE | HYDROMORPHONE HYDROCHLORIDE | 32MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204278 | PADAGIS US |