Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020882
Company: PFIZER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEURONTIN GABAPENTIN 600MG TABLET;ORAL Prescription AB Yes No
NEURONTIN GABAPENTIN 800MG 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
10/09/1998 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20882ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20882.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/18/2017 SUPPL-47 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/20235Orig1s064,020882Orig1s047,021129Orig1s046ltr.pdf
03/24/2017 SUPPL-45 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-44 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-43 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-41 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-40 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-39 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-38 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-35 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
10/11/2010 SUPPL-30 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020882s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020235s043,020882s030,021129s029ltr.pdf
04/23/2009 SUPPL-28 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-22 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-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020235s035, 020882s021, 021129s020LTR.pdf
04/30/2004 SUPPL-17 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20882scs017ltr.pdf
02/18/2005 SUPPL-15 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-12 Manufacturing (CMC)-Control

Label is not available on this site.

10/24/2002 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/15/2002 SUPPL-9 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-8 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-7 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/2000 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

10/12/2000 SUPPL-2 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/24/2017 SUPPL-45 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020235s062,020882s045,021129s044lbl.pdf
09/14/2015 SUPPL-43 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s060,020882s043,021129s042lbl.pdf
04/21/2015 SUPPL-44 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020235s061,020882s044,021129s043lbl.pdf
08/18/2014 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020235s057,020882s041,021129s039lbl.pdf
05/01/2013 SUPPL-40 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf
05/01/2013 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf
05/01/2013 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf
05/01/2013 SUPPL-38 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020235s054s055s056,020882s038s039s040,021129s035s036s037lbl.pdf
08/10/2011 SUPPL-35 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s050,020882s035,021129s033lbl.pdf
03/01/2011 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020235s036,020882s022,021129s022lbl.pdf
10/11/2010 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020882s030lbl.pdf
10/11/2010 SUPPL-30 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020882s030lbl.pdf
04/23/2009 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020235s041,020882s028,021129s027lbl.pdf
02/18/2005 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20235s029,20882s015,21129s016lbl.pdf
10/12/2000 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21216lbl.pdf

NEURONTIN

TABLET;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 203244 ACI HEALTHCARE LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 075694 ACTAVIS ELIZABETH
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 206402 ALKEM LABS LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 077661 APOTEX INC
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 200651 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 207057 CSPC OUYI
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 077662 GLENMARK PHARMS LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 202764 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 090335 MYLAN PHARMS INC
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 205101 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 077525 SUN PHARM INDS LTD
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 205807 TEVA PHARMS USA
GABAPENTIN GABAPENTIN 600MG TABLET;ORAL Prescription No AB 078926 ZYDUS PHARMS USA INC
NEURONTIN GABAPENTIN 600MG TABLET;ORAL Prescription Yes AB 020882 PFIZER PHARMS

TABLET;ORAL; 800MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 203244 ACI HEALTHCARE LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 075694 ACTAVIS ELIZABETH
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 206402 ALKEM LABS LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 077661 APOTEX INC
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 200651 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 207057 CSPC OUYI
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 077662 GLENMARK PHARMS LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 202764 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 090335 MYLAN PHARMS INC
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 205101 SCIEGEN PHARMS INC
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 077525 SUN PHARM INDS LTD
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 205807 TEVA PHARMS USA
GABAPENTIN GABAPENTIN 800MG TABLET;ORAL Prescription No AB 078926 ZYDUS PHARMS USA INC
NEURONTIN GABAPENTIN 800MG TABLET;ORAL Prescription Yes AB 020882 PFIZER PHARMS

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