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 2 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine hydrochlorideMEMANTINE HYDROCHLORIDEMacleods Pharmaceuticals Limited62e32b0b-1eb2-424d-bfd2-d27ef27d35f32025-10-14Warnings, Adverse reactionsName fallback
brand name: Memantine hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDECarlsbad Technology, Inc.30b4d5c4-0a31-c385-e063-6394a90adbce2025-06-23Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC3662b11a-354a-b683-e063-6394a90a00862025-05-30Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINERising Pharma Holdings, Inc.a282fbed-8304-458e-a0e9-5eaccc95339b2025-04-30Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAmneal Pharmaceuticals LLCf2b7538d-8ca1-4ac7-a172-d268e2fa9a522025-04-29Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC30b8b982-db74-7cf4-e063-6394a90a3a6b2025-03-19Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDECoupler LLC2d54be77-75b2-76b3-e063-6294a90a0cc02025-02-04Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochlorideMEMANTINE HYDROCHLORIDEZydus Lifesciences Limitedec825bef-2313-45c2-8858-b431976801552024-11-30Name fallback
brand name: Memantine hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutions4d48c958-b606-4427-8502-53450718eefb2024-10-21Warnings, Adverse reactionsName fallback
brand name: memantine hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
memantine hydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutions9b4e3c54-c001-47cc-bc3a-7d4bf25ccfaf2024-10-21Warnings, Adverse reactionsName fallback
brand name: memantine hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutionsca619439-f4ca-43f1-9261-9aa2b6dc74502024-09-05Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEZydus Lifesciences Limited514421f3-f525-43e8-aecc-8b2bbffd00dc2024-08-16Name fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutionsf05e381f-850d-42ea-9dd8-6d1f8dac4f622024-05-30Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack2ac7d23c-5f9f-4ffc-ae01-d7099a8a79292024-04-05Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEVitruvias Therapeutics, Inc.0c7fd6ab-2ce5-4110-b6e6-9103c8da07652024-02-16Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepack0ad2246a-ffa0-43a0-8094-58279d3e3a742024-02-06Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackbe919d34-e9f4-49c8-8145-2dcafb7cb88c2024-02-06Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutions66db6d61-cf1d-46ca-a645-19e9a20f46172023-11-24Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutions2fdf0b2b-0337-472d-83ec-075c17c9b0d02023-11-22Warnings, Adverse reactionsName fallback
brand name: Memantine Hydrochloride
generic name: MEMANTINE HYDROCHLORIDE
Memantine hydrochlorideMEMANTINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.eac265e6-6ea4-4368-acff-2efe6a8dd40a2023-10-30Warnings, 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.