FDA.reportPublic FDA data

Application 021216

Type
NDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEURONTINGABAPENTINSOLUTION; ORAL250MG/5MLNoNo

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 10 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINBryant Ranch Prepackbe9a572d-e98a-41c1-83c5-859d9176dd1c2025-10-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackeaf5e41e-8ed3-404e-84e0-392bebdbc0b72025-10-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINProficient Rx LPda8438e1-755b-4195-baa7-464f3d9ee5bd2025-10-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack8f982b95-4e84-4e0c-a543-747bc3dd75312025-09-26Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackd0510d04-460c-47d1-be72-0ee32c4ac6402025-09-26Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack344d67fa-092e-4e71-b96a-25c71bfa6bb12025-09-25Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackbc1316b6-1fc4-4990-95a8-4898817728762025-09-25Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINKesin Pharma Corporation3f2ba3d6-6086-eaf2-e063-6294a90a76422025-09-19Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
gabapentinGABAPENTINCoupler LLC3eeda97d-c3cd-65cd-e063-6394a90aae8b2025-09-16Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
gabapentinGABAPENTINZydus Lifesciences Limited8c0eeefc-ef5b-49f4-8411-ddbae312ed052025-09-15Name fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINMARKSANS PHARMA LIMITED98bb408d-c402-4da6-8f9d-5de4833dedc42025-09-12Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINEpic Pharma, LLCd592d828-8df1-480d-b179-bb9260a9c8242025-09-12Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINZydus Pharmaceuticals USA Inc.310ce005-5a24-489a-b23c-d42ab6a3bfed2025-09-08Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
gabapentinGABAPENTINZydus Pharmaceuticals USA Inc.3cfd04ab-e421-441f-a10e-e4dd1412974d2025-09-05Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINRising Pharma Holdings, Inc.b1a9808d-31a5-4b63-afd0-d96d5a0ad7a12025-09-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINMullan Pharmaceutical Inc.74474aa4-4859-42d2-92d8-f23f18b34e042025-08-21Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINDirect_Rx2cb1ad6d-d389-4564-e063-6394a90a36442025-08-19Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack137b2b9a-9d42-48d0-913f-5dc146fb689a2025-08-19Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.b4c7388a-19d9-4e3a-83c9-4943fb855be42025-08-18Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINCamber Pharmaceuticals, Inc.9ead7825-d11b-4e00-8533-328d097b8f832025-08-16Warnings, 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
44608ORIG2008-02-01
4650SUPPL2004-06-10
21515ORIG2004-05-06
27084ORIG2000-10-12
14644ORIG2000-10-12