FDA.reportPublic FDA data

Application 021424

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 8 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINA-S Medication Solutions081fd1de-acaa-4685-a053-4959d77b17e92026-02-10Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions0e1d17d5-d39c-4144-aac0-7c0d3bc9ec0d2026-02-09Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions2343e3a1-82d0-4c70-a086-a01a0ce81ef32026-02-09Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions67330eef-c976-4862-b1ae-20f30f43df762026-02-09Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINBryant Ranch Prepack2e331641-ec26-4d76-b16b-a9863c767afe2026-02-06Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackcc1998a7-7004-4688-8b5b-525041851d1d2026-02-05Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINA-S Medication Solutions4aa69d04-6b32-4764-a48b-ef5313dd95d32026-01-23Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.60b46f6d-efbc-487a-b672-b20df8b44cc42026-01-23Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINA-S Medication Solutions43a3ec78-8235-4d46-a343-2f9226745a392026-01-23Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINA-S Medication Solutions685553b0-384e-400b-a8ae-612ceece82612026-01-22Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINA-S Medication Solutions7ea0b220-edbb-45eb-aeb3-65283f8489a12026-01-22Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPreferred Pharmaceuticals, Inc.bff3beea-1f05-4e84-bcd2-d05782acddae2026-01-14Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINDIRECT RX29a70e2d-d3fd-4e32-95dd-7ee721d873882026-01-08Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
gabapentinGABAPENTINCoupler LLC47cd25f6-e123-9aaf-e063-6394a90aeedd2026-01-07Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABARONEGABAPENTININA Pharmaceutics Inc.0f350a4b-f294-4b98-b69f-3cc789e930ba2026-01-07Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAjenat Pharmaceuticals LLC02304deb-7b4a-452f-9b1a-64ca0aedbcc22025-12-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
gabapentinGABAPENTINNorthwind Health Company, LLC471b2d32-0cbd-aade-e063-6394a90a16962025-12-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINST. MARY'S MEDICAL PARK PHARMACY3aaf3d6e-c6d5-89f5-e063-6394a90a9b772025-12-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINNorthwind Health Company, LLC47214c7c-ba1b-9107-e063-6294a90a54312025-12-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBioComp Pharma, Inc.0b3a4009-42f3-c84f-e063-6294a90a80682025-12-17Warnings, 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
24147ORIG2008-02-01
36871ORIG2004-06-09
5315ORIG2004-06-09
42147ORIG2004-05-06