FDA.reportPublic FDA data

Application 021216

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 5 of 20 · 394 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GabapentinGABAPENTINCardinal Health 107, LLCb2da7d96-73ad-4f44-8784-160a384a09612026-06-03Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyf93eaa4f-cc1a-10ab-e053-6394a90a5ffc2026-06-02Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINDirect_Rxf8998c1c-c359-6f01-e053-6294a90aebf42026-06-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
gabapentinGABAPENTINProficient Rx LPc7674ea5-276b-4bb3-821b-4ac05c9e64e62026-06-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAmneal Pharmaceuticals LLC507bf6d0-e7a2-413d-9848-cd2445a1411d2026-05-30Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINLaurus Labs Limited07aa1bcc-df05-44fa-92d4-63894e0e6cd62026-05-28Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINA-S Medication Solutions03031adf-d36b-45ec-944e-dfce5a5de91a2026-05-28Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINPangea Pharmaceuticals, LLC5eff7ad8-0d31-4372-82a2-ac9f549d87962026-05-22Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINBryant Ranch Prepack397fd6d3-317b-4b61-a52b-3a09ca1d88a42026-05-22Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINBryant Ranch Prepack13640281-26b4-402e-8f69-7c81cd6e03762026-05-22Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINAmici Pharma, Inc.1ea83c18-7107-41f4-8305-62725c1c45c82026-05-19Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINCardinal Health 107, LLCd4f21e97-5e55-44c9-9b31-5f79ac2eb5122026-05-18Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
NeurontinGABAPENTINViatris Specialty LLC97935fd9-1d4a-43b6-a5d9-de994591187b2026-05-12Warnings, Adverse reactionsName fallback
brand name: Neurontin
generic name: GABAPENTIN
GabapentinGABAPENTINCardinal Health 107, LLCeeb19a5a-b31d-4df8-9546-0b2b5eb5db072026-05-07Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINMajor Pharmaceuticals152adf1d-ec0c-4561-bf80-e4c7da1587232026-05-04Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINMajor Pharmaceuticals999f3685-2eac-467e-bed2-1d0c36aaf0ed2026-05-04Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.180b99a5-7d3d-4ee5-a0cc-1ae0ede646ee2026-05-04Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.35da078b-0da0-4757-a6c4-a9144c37e8e12026-05-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GABAPENTINGABAPENTINPreferred Pharmaceuticals Inc.38119f2e-33b3-4c3c-99b7-9335d8d280d42026-05-01Warnings, Adverse reactionsName fallback
generic name: GABAPENTIN
GabapentinGABAPENTINSt. Mary's Medical Park Pharmacyb8b7e045-a7fe-8539-e053-2a95a90a40f82026-05-01Warnings, 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
44608ORIG2008-02-01
4650SUPPL2004-06-10
21515ORIG2004-05-06
27084ORIG2000-10-12
14644ORIG2000-10-12