FDA.reportPublic FDA data

Application 206528

Type
ANDA
Sponsor
AJANTA PHARMA LTD

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
A206528-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30
A206528-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206528-001AB
A206528-002AB

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 22:54:322026-06A206528-001MEMANTINE HYDROCHLORIDE5MGTABLET / ORALAB2015-11-30a50c72e98297…
2026-08-01 22:54:322026-06A206528-002MEMANTINE HYDROCHLORIDE10MGTABLET / ORALAB2015-11-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206528-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206528-002AB1a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.becb09dc-174d-4817-88d4-f38c8adcd3092026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEBryant Ranch Prepackafc07196-be28-4521-afc0-d4aa5b6fd46d2026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
ndc (product): 71335-1899
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAjanta Pharma USA Inc.292671f2-f221-4a3d-a110-a266a9527e042025-11-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
ndc (product): 27241-071
ndc (product): 27241-070
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC30b8b982-db74-7cf4-e063-6394a90a3a6b2025-03-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HCLMEMANTINE HCLDirect_Rx1289db0e-5179-d157-e063-6294a90ab7582024-02-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528
Memantine HydrochlorideMEMANTINE HYDROCHLORIDEA-S Medication Solutionsd1c2ec99-7183-46e3-a96e-4f23e20b8b062023-04-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206528
application number: ANDA206528

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27241-070Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma LimitedANDACurrent
27241-070Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma USA Inc.ANDACurrent
27241-070Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma LimitedANDACurrent
27241-070Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma USA Inc.ANDACurrent
27241-071Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma LimitedANDACurrent
27241-071Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma USA Inc.ANDACurrent
27241-071Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma LimitedANDACurrent
27241-071Memantine HydrochlorideMemantine HydrochlorideAjanta Pharma USA Inc.ANDACurrent
63629-7333Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0346Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0346Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-0346Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1899Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent
71335-1899Memantine HydrochlorideMemantine HydrochlorideBryant Ranch PrepackANDACurrent