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 16 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINDirect_Rxfbc05ceb-2e69-3c37-e053-6394a90ac4f42024-09-06Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack2dad630a-09d8-4f40-bdad-24e877a9ee382024-09-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINCreekwood Pharmaceuticals LLC26aac429-a5cd-33cc-e063-6394a90aecc02024-09-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINCreekwood Pharmaceuticals LLC266ef369-0a56-f225-e063-6294a90a495e2024-09-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBoswell Pharmacy Services LLC d/b/a BPS Wholesale1e28ad3d-2d34-a5d0-e063-6294a90adb9e2024-07-26Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a9c99dfa-f54d-9207-e053-2995a90ad43b2024-07-17Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.a9f0852e-0c58-ba22-e053-2995a90adfa02024-07-17Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack6e6b9d8f-9f9e-4760-96ea-fb8b0a3bbbdb2024-07-08Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.8f785189-bf66-36cc-e053-2a95a90a7cbc2024-06-19Name fallback
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.8e6ed5d2-40e0-1f06-e053-2a95a90aa40e2024-06-18Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINNuCare Pharmaceuticals,Inc.82c0ed15-9132-657d-e053-2991aa0ae90a2024-06-14Name fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackffe5321d-3405-46d5-a75f-c51e8f8d87b12024-05-29Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINClinical Solutions Wholesale, LLC934fefae-b895-427c-8798-4c5462b1ecc22024-04-11Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINNuCare Pharmaceuticals,Inc.ed219efc-84e3-5bdc-e053-2a95a90a56fc2024-04-11Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINClinical Solutions Wholesale, LLCdbedccfb-0e27-4119-93b9-241c039e045a2024-04-10Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack47f2a06f-4eac-4dca-aa2a-a36dd4daaea02024-04-09Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack38210141-bbdc-4186-b71f-54c72f794dca2024-04-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack75418d32-6504-4cb4-b3a9-afa0eaf19b8d2024-04-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack1ec656c9-034f-4f14-9e6b-9779d41e16272024-04-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack8de89818-805a-4a20-a9b1-48cf443b63152024-04-03Warnings, 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