FDA.reportPublic FDA data

Application 214731

Type
ANDA
Sponsor
NOVAST LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL7MGNoNo
002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL14MGNoNo
003MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL21MGNoNo
004MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL28MGNoNo

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 3 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.d1963395-3cf7-4433-bf2c-06295bb1c5b02023-10-05Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack9cfddd01-6e1d-4ee0-9310-3fb371724e3d2023-10-04Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochlorideMEMANTINEAmneal Pharmaceuticals of New York LLC054069b5-7aac-4106-821f-ebf7fd531b4f2023-08-17Warnings, Adverse reactionsName fallback
brand name: Memantine hydrochloride
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutionsd1c2ec99-7183-46e3-a96e-4f23e20b8b062023-04-19Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackbf395152-2885-4633-bf3f-2da46e7b79f12023-03-30Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack8bd5b908-f46a-4ced-9408-45984d7161492023-03-24Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack2bd37a6f-bdeb-42c2-9f03-fbf06b45cfe02023-03-03Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack54a12ddf-306b-4eb7-a7c3-c7b58df3b3722023-03-03Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackfac8c59b-5bf5-478e-8223-a5ecaa4006252023-03-03Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackc8f96b24-de66-4a17-b798-42b42a25e84c2023-03-03Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEMacleods Pharmaceuticals Limited42f0a9f2-4aa4-46fb-bc24-d3df843bb9062023-02-09Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAlembic Pharmaceuticals Limitedb86c0f6e-480b-40e7-aa4d-21bd0659101d2023-01-30Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEMacleods Pharmaceuticals Limited989fa756-7d70-4ea7-bb5e-f4395e48589d2022-12-31Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAurobindo Pharma Limitedceb733fa-4526-4b76-ab6a-bd4c5638afff2022-11-08Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDEAurobindo Pharma Limited2b2dcd54-47e0-494b-85d2-c28c3adbe7372022-11-05Warnings, Adverse reactionsName fallback
brand name: MEMANTINE HYDROCHLORIDE
generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochlorideMEMANTINE HYDROCHLORIDECamber Pharmaceuticals, Inc.910827aa-5320-446c-8f66-3f17c0ee36d92022-10-11Warnings, Adverse reactionsName fallback
brand name: memantine hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEViona Pharmaceuticals Incdcbdb62a-a4e2-4058-b73c-46005f2a5d512022-10-08Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAlembic Pharmaceuticals Inc.af2b73da-1be4-4b7f-929b-acb3b9a10f782021-10-11Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.ff74edcb-d7ed-4b70-8f22-4cb5ccc58f902020-12-07Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEDr. Reddys Laboratories Limiteda71e2482-5266-d03e-8b36-862afe78c9a42019-02-08Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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