Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022544
Company: ALMATICA
Company: ALMATICA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GRALISE | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | AB2 | Yes | Yes |
| GRALISE | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | AB2 | Yes | No |
| GRALISE | GABAPENTIN | 450MG | TABLET;ORAL | Prescription | AB | Yes | No |
| GRALISE | GABAPENTIN | 750MG | TABLET;ORAL | Prescription | AB | Yes | No |
| GRALISE | GABAPENTIN | 900MG | TABLET;ORAL | Prescription | AB | Yes | Yes |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 04/25/2025 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022544s031lbl.pdf | |
| 04/25/2025 | SUPPL-31 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022544s031lbl.pdf | |
| 04/18/2023 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022544Orig1s029lbl.pdf | |
| 09/16/2021 | SUPPL-27 | Manufacturing (CMC)-Facility | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022544Orig1s027lbl.pdf | |
| 04/02/2020 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022544s026lbl.pdf | |
| 03/27/2013 | SUPPL-12 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022544s012lbl.pdf |
| 08/08/2012 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s008lbl.pdf | |
| 01/31/2012 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s006lbl.pdf | |
| 06/28/2011 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s002lbl.pdf | |
| 01/28/2011 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s000lbl.pdf |