Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021044
Company: PURDUE PHARMA LP
Company: PURDUE PHARMA LP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PALLADONE | HYDROMORPHONE HYDROCHLORIDE | 12MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
PALLADONE | HYDROMORPHONE HYDROCHLORIDE | 16MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
PALLADONE | HYDROMORPHONE HYDROCHLORIDE | 24MG | CAPSULE, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
PALLADONE | HYDROMORPHONE HYDROCHLORIDE | 32MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
09/24/2004 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21044ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021044s000_PalladoneTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/16/2014 | SUPPL-13 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021044s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021044Orig1s013ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/16/2014 | SUPPL-13 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021044s013lbl.pdf | |
04/16/2014 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021044s013lbl.pdf | |
09/24/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021044lbl.pdf |