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 |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/28/2011 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022544_gralise_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022544Orig1s000SumR.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/25/2025 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022544s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022544Orig1s031ltr.pdf | |
| 04/18/2023 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022544Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022544Orig1s029ltr.pdf | |
| 09/16/2021 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022544Orig1s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022544Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/022544Orig1s027.pdf | |
| 04/02/2020 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022544s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022544Orig1s026ltr.pdf | |
| 03/06/2017 | SUPPL-24 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 01/09/2017 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/2013 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/2013 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/28/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/13/2013 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/2013 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/2013 | SUPPL-12 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022544s012lbl.pdf | |
| 11/30/2012 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/08/2012 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022544Orig1s008ltr.pdf | |
| 01/31/2012 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022544s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022544s006ltr.pdf | |
| 04/28/2011 | SUPPL-3 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s003ltr.pdf |
| 06/28/2011 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022544s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022544s002ltr.pdf |
| 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 |
GRALISE
TABLET;ORAL; 300MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | No | AB2 | 218075 | ANNORA PHARMA |
| GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | No | AB2 | 216252 | HUMANWELL |
| GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | No | AB2 | 218491 | SCIEGEN PHARMS |
| GABAPENTIN | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | No | AB2 | 203934 | ZYDUS PHARMS |
| GRALISE | GABAPENTIN | 300MG | TABLET;ORAL | Prescription | Yes | AB2 | 022544 | ALMATICA |
TABLET;ORAL; 600MG
TE Code = AB2
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB2 | 203643 | ABON PHARMS LLC |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB2 | 218075 | ANNORA PHARMA |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB2 | 216252 | HUMANWELL |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB2 | 218491 | SCIEGEN PHARMS |
| GABAPENTIN | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | No | AB2 | 203934 | ZYDUS PHARMS |
| GRALISE | GABAPENTIN | 600MG | TABLET;ORAL | Prescription | Yes | AB2 | 022544 | ALMATICA |
TABLET;ORAL; 450MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 450MG | TABLET;ORAL | Prescription | No | AB | 203934 | ZYDUS PHARMS |
| GRALISE | GABAPENTIN | 450MG | TABLET;ORAL | Prescription | Yes | AB | 022544 | ALMATICA |
TABLET;ORAL; 750MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 750MG | TABLET;ORAL | Prescription | No | AB | 203934 | ZYDUS PHARMS |
| GRALISE | GABAPENTIN | 750MG | TABLET;ORAL | Prescription | Yes | AB | 022544 | ALMATICA |
TABLET;ORAL; 900MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 900MG | TABLET;ORAL | Prescription | No | AB | 203934 | ZYDUS PHARMS |
| GRALISE | GABAPENTIN | 900MG | TABLET;ORAL | Prescription | Yes | AB | 022544 | ALMATICA |