FDA.reportPublic FDA data

Application 205825

Type
ANDA
Sponsor
AMNEAL PHARMS

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 · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205825-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12
A205825-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12
A205825-003MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12
A205825-004MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A205825-001AB
A205825-002AB
A205825-003AB
A205825-004AB

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 22:54:322026-06A205825-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12a50c72e98297…
2026-08-01 22:54:322026-06A205825-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12a50c72e98297…
2026-08-01 22:54:322026-06A205825-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12a50c72e98297…
2026-08-01 22:54:322026-06A205825-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-10-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205825-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205825-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A205825-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A205825-004AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAmneal Pharmaceuticals LLCf2b7538d-8ca1-4ac7-a172-d268e2fa9a522025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205825
application number: ANDA205825
ndc (product): 65162-785
ndc (product): 65162-782
ndc (product): 65162-784
ndc (product): 65162-783

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
65162-782Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-782Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-782Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-782Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-783Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-783Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-783Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-783Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-784Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-784Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-784Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-784Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-785Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-785Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-785Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent
65162-785Memantine HydrochlorideMemantine HydrochlorideAmneal Pharmaceuticals LLCANDACurrent