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 2 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEBAJAJ MEDICAL, LLC38fccce5-1f1e-9350-e063-6394a90a045a2025-07-02Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepacke3eb34af-6e25-4a3d-a7d2-e9a789e335cc2025-06-26Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HClAMANTADINE HYDROCHLORIDEAvPAK461e6444-189e-62ed-6c61-1c36a04459c62025-06-24Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HClAMANTADINE HYDROCHLORIDEAvKAREbfd129ae-8b0a-f118-b7d0-45d106290b632025-06-24Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HClAMANTADINE HYDROCHLORIDEBionpharma Inc.d6ca4d20-72c5-496c-9ac7-1f5cb407a7422025-06-09Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEEPIC PHARMA LLC0f70c79a-92a4-4a38-bbdd-900adc4c2e932025-06-06Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.1b9498b7-125e-4314-baca-b62af6e5511c2025-06-06Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDERising Pharma Holdings, Inc.6fd54e00-a714-4442-af95-2515ab3b2ac32025-06-04Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.609dc911-1e9d-4ebd-b64b-f44054e5582e2025-06-04Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochlorideAMANTADINE HYDROCHLORIDEZydus Lifesciences Limited579e6c23-6286-4b80-88de-c86c0e5cc2b22025-06-04Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.6311b46b-23cc-40c1-93c2-f7c92606386f2025-05-12Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDECoupler LLC2d94073b-c064-c280-e063-6294a90af1452025-02-07Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEProficient Rx LPa3810649-1301-4332-85df-722b36867b1b2025-02-01Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
amantadine hydrochlorideAMANTADINE HYDROCHLORIDECoupler LLC2cb6e83d-e635-b150-e063-6294a90ad61d2025-01-27Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEBryant Ranch Prepack1f3c7c37-c488-4a88-8251-7db52dc038272024-11-04Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEChartwell RX, LLCa016ab57-d18f-4a3b-b2ab-f91fecc1eef72024-10-10Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labsb54064bc-b3e1-4d83-be40-fcaddd2e99d02024-08-05Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEPatrin Pharma, Inc.0fcf5182-a666-4f38-879f-47f19de30dd52024-05-20Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEAmerican Health Packaging5a8f16cc-e5d5-4097-8297-10c8166c7a0e2024-02-21Warnings, Adverse reactionsName fallback
generic name: AMANTADINE HYDROCHLORIDE
Amantadine HydrochlorideAMANTADINE HYDROCHLORIDEStrides Pharma Science Limited20dad861-6ad1-4660-b315-8af57b2941752023-07-17Warnings, 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
40739SUPPL2011-01-04
33235SUPPL2009-01-06
13099SUPPL2009-01-06
33234SUPPL2004-04-27
13098SUPPL2003-09-29