FDA.reportPublic FDA data

Application 204033

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDESOLUTION;ORAL2MG/MLNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A204033-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE2MG/MLSOLUTION / ORALAARS2015-10-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A204033-001AA

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204033-001MEMANTINE HYDROCHLORIDE2MG/MLSOLUTION / ORALAARS2015-10-13a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204033-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.d1f97615-e888-421e-b50a-95a87a1965ff2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204033
application number: ANDA204033
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEChartwell RX, LLCa7b76864-6de7-45f6-be5b-5ecfca8116272026-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204033
application number: ANDA204033
ndc (product): 62135-943

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0121-0850Memantine HydrochlorideMemantine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0121-0850Memantine HydrochlorideMemantine HydrochloridePharmaceutical Associates, Inc.ANDACurrent
0527-1943Memantine HydrochlorideMemantine HydrochlorideLannett Company, Inc.ANDACurrent
0527-1943Memantine HydrochlorideMemantine HydrochlorideLannett Company, Inc.ANDACurrent
0527-1943Memantine HydrochlorideMemantine HydrochlorideLannett Company, Inc.ANDACurrent
0527-1943Memantine HydrochlorideMemantine HydrochlorideLannett Company, Inc.ANDACurrent
0527-1943Memantine HydrochlorideMemantine HydrochlorideLannett Company, Inc.ANDACurrent
62135-943Memantine HydrochlorideMemantine HydrochlorideChartwell RX, LLCANDACurrent