FDA.reportPublic FDA data

Application 018101

Type
NDA
Sponsor
ENDO PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYMMETRELAMANTADINE HYDROCHLORIDETABLET;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018101-001SYMMETRELAMANTADINE HYDROCHLORIDE100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N018101-001SYMMETREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018101-001SYMMETREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N018101-001SYMMETREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N018101-001SYMMETREL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

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 1 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEAvKARE547904f3-84a3-1ccb-e063-6294a90a6fb62026-06-17Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEA-S Medication Solutionsda693bb0-0cc8-485d-89a7-c8cf28d440f32026-05-15Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepack6326d7f5-4c7c-4541-8db1-c582f1525f602026-04-15Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDECardinal Health 107, LLC5989098d-2855-4b5f-9a06-64a83656c0782026-04-08Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEZhejiang Jutai Pharmaceutical Co., Ltd.9c5e0c61-372b-4d1b-8882-e13f6af8fed02026-03-26Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEStrides Pharma Inc.e4d8f36f-d668-4728-8dca-b1c22bd9aedb2026-01-30Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEMajor Pharmaceuticalsb2f7da34-ad78-4db3-9af1-bdd341e09f162026-01-05Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.3c448cb3-7996-4a83-a9ad-23a00a431fbe2025-12-19Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEStrides Pharma Inc.9a99bb98-82a4-4b9e-9216-554dade72a3c2025-12-12Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEChartwell RX, LLC52aa093c-82cc-4d81-b072-86a2b8adc9c52025-12-12Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEUpsher-Smith Laboratories, LLC63d9d4aa-5f92-45b0-98d0-d6ec38b727cb2025-12-11Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepack56b923c3-1d4a-47bf-9c9e-c0fdc54c8a2f2025-10-24Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepack96aefbca-fe71-42ef-8079-d0d9e7370ccb2025-10-22Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepacka10bf8b5-bf70-4090-b4b2-a0be252b9fe42025-10-22Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEMarlex Pharmaceuticals Inc25af52ee-9b29-4c07-a383-62d4537b63e02025-09-10Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY3dd7f2a6-5a91-81a2-e063-6294a90a33db2025-09-02Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEPAI Holdings, LLC dba PAI Pharmabe411327-5ac7-46df-b5e4-32a11b419b152025-08-07Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepack8e578f11-6112-4a1f-8de4-a76870bb62c72025-07-14Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEAdvagen Pharma Limitedc3b9e7f0-be6d-4f37-9277-54bb0ba8b1582025-07-09Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEUpsher-Smith Laboratories, LLC5232b933-1df9-43b4-8ac2-61bfa4855e682025-07-09Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33435SUPPL2009-02-04
842SUPPL2009-02-03
11163SUPPL2008-10-03
841SUPPL2008-09-26
11162SUPPL2007-03-07
840SUPPL2007-03-07
40778SUPPL2006-05-08
11161SUPPL2004-04-27
839SUPPL2003-11-25