Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022462
Company: PIRAMAL CRITICAL
Company: PIRAMAL CRITICAL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GABLOFEN | BACLOFEN | 0.05MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | Yes | Yes |
| GABLOFEN | BACLOFEN | 0.5MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | Yes | Yes |
| GABLOFEN | BACLOFEN | 2MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | Yes | Yes |
| GABLOFEN | BACLOFEN | 1MG/ML | INJECTABLE;INTRATHECAL | Prescription | AP | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/31/2022 | SUPPL-15 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022462Orig1s015Lbl.pdf | |
| 04/19/2021 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022462s013lbl.pdf | |
| 12/19/2019 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022462s011lbl.pdf | |
| 02/11/2015 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022462s008lbl.pdf | |
| 11/19/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022462s000lbl.pdf |