Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020075
Company: AMNEAL
Company: AMNEAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIORESAL | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | Yes | Yes |
| LIORESAL | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | Yes | Yes |
| LIORESAL | BACLOFEN | 0.05MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/13/2021 | SUPPL-38 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020075Orig1s038lbl.pdf | |
| 01/16/2019 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020075s037lbl.pdf | |
| 09/30/2016 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020075s032lbl.pdf | |
| 11/19/2013 | SUPPL-28 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s028lbl.pdf | |
| 03/06/2013 | SUPPL-26 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020075s026lbl.pdf |
| 11/13/2011 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s024lbl.pdf | |
| 03/25/2011 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020075s021lbl.pdf |