FDA.reportPublic FDA data

Application 206028

Type
ANDA
Sponsor
LUPIN 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 · 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
A206028-001MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28
A206028-002MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28
A206028-003MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28
A206028-004MEMANTINE HYDROCHLORIDEMEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206028-001AB
A206028-002AB
A206028-003AB
A206028-004AB

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 22:54:322026-06A206028-001MEMANTINE HYDROCHLORIDE7MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…
2026-08-01 22:54:322026-06A206028-002MEMANTINE HYDROCHLORIDE14MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…
2026-08-01 22:54:322026-06A206028-003MEMANTINE HYDROCHLORIDE21MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…
2026-08-01 22:54:322026-06A206028-004MEMANTINE HYDROCHLORIDE28MGCAPSULE, EXTENDED RELEASE / ORALAB2016-09-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206028-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206028-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A206028-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A206028-004AB1a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
memantine hydrochlorideMEMANTINE HYDROCHLORIDELupin Pharmaceuticals, Inc.24290655-47f3-4042-a977-a832c5161d2c2026-01-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206028
application number: ANDA206028
ndc (product): 68180-246
ndc (product): 68180-247
ndc (product): 68180-248
ndc (product): 68180-249
memantine hydrochlorideMEMANTINE HYDROCHLORIDEMajor Pharmaceuticalsf6ce7cca-d245-44f2-986c-2a8d85dbb5fb2026-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206028
application number: ANDA206028
ndc (product): 0904-6735
ndc (product): 0904-6737
ndc (product): 0904-6734
ndc (product): 0904-6736

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8264memantine hydrochloridememantine hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6734memantine hydrochloridememantine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6735memantine hydrochloridememantine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6735memantine hydrochloridememantine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6736memantine hydrochloridememantine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6736memantine hydrochloridememantine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6737memantine hydrochloridememantine hydrochlorideMajor PharmaceuticalsANDACurrent
68180-246memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-246memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-246memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-246memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-247memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-247memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-247memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-247memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-248memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-248memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-248memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-248memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-249memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-249memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-249memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent
68180-249memantine hydrochloridememantine hydrochlorideLupin Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45605ORIG2016-10-11
45445ORIG2016-10-03