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 12 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacy7d3fc163-25f0-2c61-e053-2991aa0a76e92025-05-23Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAmneal Pharmaceuticals LLC772d9e7a-3811-455a-99e6-f2a3d0769b9b2025-05-13Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAurobindo Pharma Limited1a619a14-0b63-4cba-80e7-474c9a1c90b92025-05-12Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAurobindo Pharma Limited25cf6c40-a239-4dd0-9cad-28da84d285db2025-05-09Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP3c8dca11-78ab-45c1-8bb2-89a41ea5dfa92025-05-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINExelan Pharmaceuticals, Inc.41d1ead3-046e-4abf-ae0a-cb126a1f58482025-05-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINActavis Pharma, Inc.5969871e-6c71-4c37-9d63-370718ccc80c2025-05-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINCipla USA Inc.9e4eca9c-6a2c-4ede-a252-1a27094bf5942025-05-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINDirect_Rx30a2ed14-dcda-f972-e063-6294a90a417c2025-04-23Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINMcKesson Corporation dba Sky Packaging23eb133e-2f74-4219-9892-0a8e770ec0322025-04-17Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINMylan Pharmaceuticals Inc.cff7de45-148b-4e96-88fd-6052bf75b5f72025-04-12Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINWestminster Pharmaceuticals, LLC3ad96553-73a4-4a9b-8a89-10a29b794ed32025-04-04Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINProficient Rx LP7fcce531-bf7c-43b6-bea9-8f0602842c532025-04-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINCoupler LLC3133c863-d33b-c9d7-e063-6294a90ae8982025-03-25Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINCoupler LLC3133fc78-dd7a-880c-e063-6394a90a89e12025-03-25Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINPrecision Dose, Inc.86c93d8b-6286-44e2-93dd-f1b10a5d83da2025-03-10Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP87b9171b-7d00-40fa-87ff-a717740efe8a2025-03-02Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP64a65366-8577-48f2-9f8e-0332f126d3c12025-03-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINNuCare Pharmaceuticals, Inc.200b61d7-6e4c-923d-e063-6294a90a42cf2025-02-21Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINBryant Ranch Prepack35ac6b11-7b1c-47a0-a4ba-c193a0bb5b012025-02-20Warnings, 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