Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020235
Company: PFIZER PHARMS
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
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-Medication Guide, 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
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 Labeling, REMS-Proposal 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
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-Medication Guide 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
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 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020235s043lbl.pdf
10/11/2010 SUPPL-43 REMS-Proposal 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 HEALTHCARE LTD
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 075360 APOTEX INC
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 078787 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 207099 EPIC PHARMA LLC
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 091008 JIANGSU HENGRUI MED
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 090158 MYLAN
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 PHARM
GABAPENTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription No AB 075435 TEVA PHARMS
NEURONTIN GABAPENTIN 100MG CAPSULE;ORAL Prescription Yes AB 020235 PFIZER 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 206943 ACI HEALTHCARE LTD
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 075360 APOTEX INC
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 078787 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 207099 EPIC PHARMA LLC
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 091008 JIANGSU HENGRUI MED
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 090158 MYLAN
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 PHARM
GABAPENTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription No AB 075435 TEVA PHARMS
NEURONTIN GABAPENTIN 300MG CAPSULE;ORAL Prescription Yes AB 020235 PFIZER 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 206943 ACI HEALTHCARE LTD
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 075360 APOTEX INC
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 078787 AUROBINDO PHARMA LTD
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 207099 EPIC PHARMA LLC
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090705 INVAGEN PHARMS
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 091008 JIANGSU HENGRUI MED
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090007 MARKSANS PHARMA
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 090158 MYLAN
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 PHARM
GABAPENTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription No AB 075435 TEVA PHARMS
NEURONTIN GABAPENTIN 400MG CAPSULE;ORAL Prescription Yes AB 020235 PFIZER PHARMS

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