FDA.reportPublic FDA data

Application 021397

Type
NDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEURONTINGABAPENTINTABLET; ORAL600MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 11 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINExelan Pharmaceuticals, Inc.a88edb00-2189-4c8d-9dd7-9fe1571775cc2025-08-16Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINXLCare Pharmaceuticals, Inc.707ed63a-67ca-4a62-9cbe-cdeb5c4ab5062025-08-16Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINXLCare Pharmaceuticals, Inc.618c948d-deee-44e2-98f0-e5232171dd502025-08-04Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackca8177ed-1f0d-436e-a5ac-f58b8f7cbb252025-07-28Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack2278ce1b-1c19-4ad2-89c6-4530f7b78ea72025-07-14Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINNorthStar Rx LLC9508cb1b-3f9f-48bd-8f34-a6fbb68c9a4a2025-07-11Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
gabapentinGABAPENTINScieGen Pharmaceuticals, Inc.3f2e3ac5-5233-fd57-e063-6294a90a849e2025-07-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.7c3b232a-3e9f-4249-9e5a-295482ee288a2025-06-27Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINNorthStar Rx LLCf7c1fd34-d615-43a2-8989-898fe11f90df2025-06-25Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutionsd25daaac-a8ab-4f12-acc2-4ec8fc97a2d42025-06-24Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINQUALLENT PHARMACEUTICALS HEALTH LLC472bb279-bb4e-4246-b2a3-172483ba356b2025-06-23Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.5d3f27bf-3486-40fa-a4d3-5f0b2c6c01512025-06-11Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.561f53d5-5301-42b3-b372-f3d49d642a2e2025-06-11Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINDirect_Rxed9c501c-24e4-da89-e053-2a95a90a64c62025-06-09Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.11645bd6-7cfe-49b2-9292-2e4b0dbb84ae2025-06-04Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
gabapentinGABAPENTINRising Pharma Holdings, Inc.969cccfc-e56a-49da-9d36-47c0c3fad7f82025-06-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPAI Holdings, LLC dba PAI Pharma6d3fd1f9-c831-4262-af10-291838a535412025-05-31Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINRising Pharma Holdings, Inc.8215da86-d7af-4980-b6d6-4bd46f6bfeaf2025-05-30Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINATLANTIC BIOLOGICALS CORP.5969f1a8-d6d5-4967-add5-4e2492354d7b2025-05-27Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.0ce53f62-1738-43f4-9a2e-c5dc42a91d092025-05-26Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24145ORIG2008-02-01
36816ORIG2004-06-09
27664ORIG2004-06-09
21635ORIG2004-05-06