Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204989
Company: SCIEGEN PHARMS
Company: SCIEGEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RELGAABI | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | AB | No | No |
| RELGAABI | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | AB | No | No |
| RELGAABI | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | AB | No | No |
| RELGAABI | GABAPENTIN | 200MG | CAPSULE;ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 02/18/2016 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204989Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/17/2026 | SUPPL-40 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/31/2024 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/31/2024 | SUPPL-32 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/31/2024 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2020 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2020 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/29/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
RELGAABI
CAPSULE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 075350 | ACTAVIS ELIZABETH |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 090858 | ALKEM |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 078428 | AMNEAL PHARMS NY |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 214956 | ASCENT PHARMS INC |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 078787 | AUROBINDO PHARMA |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 075477 | CSPC OUYI |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 075360 | GRANULES |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 090705 | INVAGEN PHARMS |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 217546 | LAURUS |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 090007 | MARKSANS PHARMA |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 219814 | PRINSTON INC |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 207099 | RISING |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 219319 | SENORES PHARMS |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 206943 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211314 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 213603 | ZHEJIANG YONGTAI |
| NEURONTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 020235 | VIATRIS |
| RELGAABI | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 204989 | SCIEGEN PHARMS |
CAPSULE;ORAL; 300MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 075350 | ACTAVIS ELIZABETH |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 090858 | ALKEM |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 078428 | AMNEAL PHARMS NY |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 214956 | ASCENT PHARMS INC |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 078787 | AUROBINDO PHARMA |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 075477 | CSPC OUYI |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 075360 | GRANULES |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 090705 | INVAGEN PHARMS |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 217546 | LAURUS |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 090007 | MARKSANS PHARMA |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 219814 | PRINSTON INC |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 207099 | RISING |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 219319 | SENORES PHARMS |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 206943 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 211314 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 213603 | ZHEJIANG YONGTAI |
| NEURONTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | Yes | AB | 020235 | VIATRIS |
| RELGAABI | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 204989 | SCIEGEN PHARMS |
CAPSULE;ORAL; 400MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 075350 | ACTAVIS ELIZABETH |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 090858 | ALKEM |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 078428 | AMNEAL PHARMS NY |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 214956 | ASCENT PHARMS INC |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 078787 | AUROBINDO PHARMA |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 075477 | CSPC OUYI |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 075360 | GRANULES |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 090705 | INVAGEN PHARMS |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 217546 | LAURUS |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 090007 | MARKSANS PHARMA |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 219814 | PRINSTON INC |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 207099 | RISING |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 219319 | SENORES PHARMS |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 206943 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 211314 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 213603 | ZHEJIANG YONGTAI |
| NEURONTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | Yes | AB | 020235 | VIATRIS |
| RELGAABI | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 204989 | SCIEGEN PHARMS |