Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020235
Company: VIATRIS
Company: VIATRIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NEURONTIN | GABAPENTIN | 100MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| NEURONTIN | GABAPENTIN | 300MG | CAPSULE;ORAL | Prescription | AB | Yes | No |
| NEURONTIN | GABAPENTIN | 400MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 12/30/1993 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/16/2020 | SUPPL-69 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s069,020882s050,021129s050lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020235Orig1s069, 020882Orig1s050, 021129Orig1s050ltr.pdf | |
| 04/02/2020 | SUPPL-68 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s068,020882s049,021129s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020235Orig1s068, 020882Orig1s049, 021129Orig1s049ltr.pdf | |
| 10/18/2017 | SUPPL-64 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s064_020882s047_021129s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/20235Orig1s064,020882Orig1s047,021129Orig1s046ltr.pdf | |
| 03/24/2017 | SUPPL-62 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020235Orig1s062,020882Orig1s045,021129Orig1s044ltr.pdf | |
| 04/21/2015 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s061,020882s044,021129s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s061,020882Orig1s044,021129Orig1s043ltr.pdf | |
| 09/14/2015 | SUPPL-60 | Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s060,020882s043,021129s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020235Orig1s060,020882s043,021129Orig1s042ltr.pdf | |
| 08/18/2014 | SUPPL-57 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020235s057,020882s041,021129s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020235Orig1s057,020882Orig1s041,021129Orig1s039ltr.pdf | |
| 05/01/2013 | SUPPL-56 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf | |
| 05/01/2013 | SUPPL-55 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf | |
| 05/01/2013 | SUPPL-54 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020235Orig1s054,s055,s056,020882Orig1s038,s039,s040,021129Orig1s035,s036,s037ltr.pdf | |
| 08/10/2011 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s050,020882s035,021129s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s050,020882s035,021129s033ltr.pdf | |
| 11/20/2009 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/11/2010 | SUPPL-43 | REMS-Proposal, Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020235s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020235s043,020882s030,021129s029ltr.pdf | |
| 04/23/2009 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020235s041,020882s028,021129s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020235s041,020882s028ltr.pdf | |
| 03/01/2011 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s036,020882s022,021129s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020235s036,020882s022,021129s022ltr.pdf | |
| 05/03/2006 | SUPPL-35 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020235s035, 020882s021, 021129s020LTR.pdf |
| 02/18/2005 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20235s029,20882s015,21129s016ltr.pdf | |
| 12/19/2002 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/24/2002 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/15/2002 | SUPPL-23 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20235se8-023,20882se8-009,21129se8-010ltr.pdf |
| 01/30/2002 | SUPPL-22 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21129s9ltr.pdf |
| 01/18/2002 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/2001 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/2001 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/2001 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/2000 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/21/2000 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/2000 | SUPPL-15 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21216ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-216_20-235S15_20-882S2_21-129S5_Neurontin.cfm | |
| 05/15/2000 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1998 | SUPPL-11 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20235s11lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20235s11ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020235S011.pdf | |
| 02/12/1998 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/09/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1996 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/14/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/16/2020 | SUPPL-69 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s069,020882s050,021129s050lbl.pdf | |
| 12/16/2020 | SUPPL-69 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s069,020882s050,021129s050lbl.pdf | |
| 04/02/2020 | SUPPL-68 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s068,020882s049,021129s049lbl.pdf | |
| 04/02/2020 | SUPPL-68 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020235s068,020882s049,021129s049lbl.pdf | |
| 10/18/2017 | SUPPL-64 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s064_020882s047_021129s046lbl.pdf | |
| 03/24/2017 | SUPPL-62 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf | |
| 09/14/2015 | SUPPL-60 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s060,020882s043,021129s042lbl.pdf | |
| 04/21/2015 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s061,020882s044,021129s043lbl.pdf | |
| 08/18/2014 | SUPPL-57 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020235s057,020882s041,021129s039lbl.pdf | |
| 05/01/2013 | SUPPL-56 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf | |
| 05/01/2013 | SUPPL-55 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf | |
| 05/01/2013 | SUPPL-54 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf | |
| 05/01/2013 | SUPPL-54 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf | |
| 08/10/2011 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s050,020882s035,021129s033lbl.pdf | |
| 03/01/2011 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s036,020882s022,021129s022lbl.pdf | |
| 10/11/2010 | SUPPL-43 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020235s043lbl.pdf | |
| 10/11/2010 | SUPPL-43 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020235s043lbl.pdf | |
| 04/23/2009 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020235s041,020882s028,021129s027lbl.pdf | |
| 02/18/2005 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s016lbl.pdf | |
| 10/12/2000 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf | |
| 09/29/1998 | SUPPL-11 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20235s11lbl.pdf |
NEURONTIN
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 | 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 | 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 | 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 |