Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019892
Company: RHODES PHARMS
Company: RHODES PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 8MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 4MG | TABLET;ORAL | Prescription | AB | Yes | No |
DILAUDID | HYDROMORPHONE HYDROCHLORIDE | 2MG | TABLET;ORAL | Prescription | AB | Yes | No |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
12/15/2023 | SUPPL-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019891s031,019892s041lbl.pdf | |
03/04/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019891s029,019892s037lbl.pdf | |
10/07/2019 | SUPPL-35 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf | |
10/07/2019 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019891s028,019892s035lbl.pdf | |
09/18/2018 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf | |
09/18/2018 | SUPPL-33 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019891s026s027,019892s033s034lbl.pdf | |
12/16/2016 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf | |
12/16/2016 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019891s024,019892s029lbl.pdf | |
11/09/2007 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019892s015lbl.pdf | |
06/12/2006 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019892s009,019891s008lbl.pdf |