Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075350
Company: ACTAVIS ELIZABETH
Company: ACTAVIS ELIZABETH
| 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 |
|---|---|---|---|---|---|---|---|
| 09/12/2003 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/075350_ORIGINAL APPROVAL_PACKAGE.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/29/2026 | SUPPL-80 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2025 | SUPPL-77 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/07/2025 | SUPPL-72 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/26/2021 | SUPPL-67 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/21/2020 | SUPPL-66 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 07/21/2020 | SUPPL-60 | Labeling-Package Insert, Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/13/2016 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2015 | SUPPL-54 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/13/2016 | SUPPL-49 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/11/2012 | SUPPL-35 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/28/2012 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2011 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2011 | SUPPL-28 | Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |
||
| 05/13/2010 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/05/2006 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 12/23/2005 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/08/2005 | SUPPL-4 | Labeling |
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 | 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 |