FDA.reportPublic FDA data

Application 017118

Type
NDA
Sponsor
ENDO PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SYMMETRELAMANTADINE HYDROCHLORIDESYRUP; ORAL50MG/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 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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
40739SUPPL2011-01-04
33235SUPPL2009-01-06
13099SUPPL2009-01-06
33234SUPPL2004-04-27
13098SUPPL2003-09-29