Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090705
Company: INVAGEN PHARMS
Company: INVAGEN PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | AB | No | No |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | AB | No | No |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 12/30/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/18/2023 | SUPPL-31 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/08/2020 | SUPPL-27 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/08/2020 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/08/2020 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/03/2016 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/03/2016 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/03/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/30/2014 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/11/2012 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2011 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
GABAPENTIN
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 | 206943 | ACI |
| 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 | 207099 | GRAVITI PHARMS |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 090705 | INVAGEN PHARMS |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208928 | IPCA LABS LTD |
| 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 | 204989 | SCIEGEN PHARMS INC |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 211314 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077242 | SUN PHARM INDS LTD |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 077261 | TARO |
| GABAPENTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | No | AB | 213603 | ZHEJIANG YONGTAI |
| NEURONTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | Yes | AB | 020235 | VIATRIS |
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 | 206943 | ACI |
| 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 | 207099 | GRAVITI PHARMS |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 090705 | INVAGEN PHARMS |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 208928 | IPCA LABS LTD |
| 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 | 204989 | SCIEGEN PHARMS INC |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 211314 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 077242 | SUN PHARM INDS LTD |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 077261 | TARO |
| GABAPENTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | No | AB | 213603 | ZHEJIANG YONGTAI |
| NEURONTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | Yes | AB | 020235 | VIATRIS |
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 | 206943 | ACI |
| 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 | 207099 | GRAVITI PHARMS |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 090705 | INVAGEN PHARMS |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 208928 | IPCA LABS LTD |
| 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 | 204989 | SCIEGEN PHARMS INC |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 211314 | STRIDES PHARMA |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 077242 | SUN PHARM INDS LTD |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 077261 | TARO |
| GABAPENTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | No | AB | 213603 | ZHEJIANG YONGTAI |
| NEURONTIN | GABAPENTIN | 400MG | CAPSULE;ORAL | Prescription | Yes | AB | 020235 | VIATRIS |