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 3 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy3c585b71-5cfc-18d6-e063-6294a90a3dcf2026-07-17Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack172776c0-909e-49ce-bfe1-cf154a9458ba2026-07-15Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepacka1006139-7dfc-4d87-a5a9-aeb380c32d242026-07-15Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackdf9c7c84-a8d9-4da8-babe-c55c9420d4e62026-07-15Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINREMEDYREPACK INC.6beed8eb-446c-4575-8dc8-b798623d92c72026-07-15Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINREMEDYREPACK INC.7ddc7d92-9076-41cf-97ed-d9f9edc802982026-07-15Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack72729513-bd34-44f5-9f62-297ed25c44422026-07-15Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackf31172a2-0ae9-49f2-b797-b26fe33f3f642026-07-15Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepack6a0a75ac-e121-477b-a9d1-d11f588afc9d2026-07-14Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBryant Ranch Prepackb6db5ce9-bd4b-420d-88a7-df9d46144c812026-07-10Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPD-Rx Pharmaceuticals, Inc.9b175f8d-7667-4bfe-8bb5-fd7441eed4562026-07-08Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy4ddcdff5-8f1f-bff3-e063-6294a90a11952026-07-07Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINHAWAII REPACK, INC.dd7adad2-e2f5-4b43-90a4-522bce0be5b32026-07-02Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINHAWAII REPACK, INC.f6ff265b-569b-4f5c-8fdb-00b7ad4aac7c2026-07-02Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
gabapentinGABAPENTINSun Pharmaceutical Industries, Inc.c9a05f0c-b5f0-422c-9d67-6d0efc921a742026-07-02Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINStrides Pharma Science Limited43b67ae3-ac6f-48f5-8788-9ead083768642026-07-02Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP9d401e54-d4f5-43ba-b898-dd08fc3c7bfa2026-07-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GraliseGABAPENTINAlmatica Pharma LLC466273b1-c9fc-3930-c94b-aa11394d51402026-06-30Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINHAWAII REPACK, INC.14d61caa-17ce-4fa2-90fb-1470f3864be82026-06-26Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy2bc65375-77b8-1e50-e063-6294a90acf8f2026-06-26Warnings, 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
24147ORIG2008-02-01
36871ORIG2004-06-09
5315ORIG2004-06-09
42147ORIG2004-05-06