FDA.reportPublic FDA data

Application 090058

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDETABLET;ORAL10MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090058-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05
A090058-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090058-001AB
A090058-002AB

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 22:54:322026-06A090058-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2010-05-05a50c72e98297…
2026-08-01 22:54:322026-06A090058-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2010-05-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090058-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A090058-002AB1a50c72e98297…

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 HYDROCHLORIDEBryant Ranch Prepack2ac7d23c-5f9f-4ffc-ae01-d7099a8a79292024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090058
application number: ANDA090058
ndc (product): 71335-1908
Memantine HydrochlorideMEMANTINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.d1963395-3cf7-4433-bf2c-06295bb1c5b02023-10-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090058
application number: ANDA090058
ndc (product): 47335-321
ndc (product): 47335-322

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-321Memantine HydrochlorideMemantine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-321Memantine HydrochlorideMemantine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-321Memantine HydrochlorideMemantine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-322Memantine HydrochlorideMemantine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-322Memantine HydrochlorideMemantine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-322Memantine HydrochlorideMemantine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
50090-4203Memantine HydrochlorideMemantine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4203Memantine HydrochlorideMemantine HydrochlorideA-S Medication SolutionsANDACurrent
67046-458Memantine HydrochlorideMemantine HydrochlorideContract Pharmacy Services-PAANDACurrent
71335-1908Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent