FDA.reportPublic FDA data

Application 021423

Type
NDA
Sponsor
PARKE DAVIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEURONTINGABAPENTINCAPSULE; ORAL800MGNoNo

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 20 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GABAPENTINGABAPENTINProficient Rx LP92c4d589-533b-4fe4-833f-dd68cc1f7e662019-11-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LP2ef99c3d-866a-438b-a340-8beba8d4c4572019-11-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINProficient Rx LPc78f528f-9192-4037-bfb9-ff5718ed26c52019-10-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINEpic Pharma, LLC030e656a-e384-49ac-830f-32140c18112d2019-01-07Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLCa900bafb-8f49-4a01-ba7f-4fb228ec02532018-11-12Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC6702ed8f-4aaf-46fa-bf39-db75154aa44c2018-10-19Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC1b73e9db-eddb-49ba-9778-01d39ece4d162018-09-21Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLCf455b415-12a2-4916-b826-246976a8af442018-09-12Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC5fbd601f-df95-4a79-a7d3-c3505e23b9132018-09-06Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINAphena Pharma Solutions - Tennessee, LLC9d1b9121-c25a-4d28-91c5-5fc72f1167f42018-07-12Name fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC37d4d465-19a5-46db-80dc-0b7334b3343a2018-06-25Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC6fc8e8b2-5d0e-4c72-9a46-6d312c3efac72018-05-14Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAphena Pharma Solutions - Tennessee, LLC86b30e64-fe56-42b3-a0f8-d9ef5d4b8c492016-06-20Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINBi-Coastal Pharma International LLCe0cd96d1-b1ef-46ec-a5a3-9505b0811b8b2016-04-17Warnings, 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
24146ORIG2008-02-01
36870ORIG2004-06-09
27726ORIG2004-06-09
42146ORIG2004-05-06