FDA.reportPublic FDA data

Application 218535

Type
ANDA
Sponsor
ALEMBIC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPATABLET;ORAL12.5MG;200MG;50MGNoNo
002CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPATABLET;ORAL18.75MG;200MG;75MGNoNo
003CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPATABLET;ORAL25MG;200MG;100MGNoNo
004CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPATABLET;ORAL31.25MG;200MG;125MGNoNo
005CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPATABLET;ORAL37.5MG;200MG;150MGNoNo
006CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPATABLET;ORAL50MG;200MG;200MGNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218535-001CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA12.5MG;200MG;50MGTABLET / ORALAB2026-02-05
A218535-002CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA18.75MG;200MG;75MGTABLET / ORALAB2026-02-05
A218535-003CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA25MG;200MG;100MGTABLET / ORALAB2026-02-05
A218535-004CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA31.25MG;200MG;125MGTABLET / ORALAB2026-02-05
A218535-005CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA37.5MG;200MG;150MGTABLET / ORALAB2026-02-05
A218535-006CARBIDOPA, LEVODOPA AND ENTACAPONECARBIDOPA; ENTACAPONE; LEVODOPA50MG;200MG;200MGTABLET / ORALAB2026-02-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A218535-001AB
A218535-002AB
A218535-003AB
A218535-004AB
A218535-005AB
A218535-006AB

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
2026-02-19 14:30 UTC2026-02A218535-001CARBIDOPA, LEVODOPA AND ENTACAPONE12.5MG;200MG;50MGTABLET / ORALAB2026-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218535-002CARBIDOPA, LEVODOPA AND ENTACAPONE18.75MG;200MG;75MGTABLET / ORALAB2026-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218535-003CARBIDOPA, LEVODOPA AND ENTACAPONE25MG;200MG;100MGTABLET / ORALAB2026-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218535-004CARBIDOPA, LEVODOPA AND ENTACAPONE31.25MG;200MG;125MGTABLET / ORALAB2026-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218535-005CARBIDOPA, LEVODOPA AND ENTACAPONE37.5MG;200MG;150MGTABLET / ORALAB2026-02-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218535-006CARBIDOPA, LEVODOPA AND ENTACAPONE50MG;200MG;200MGTABLET / ORALAB2026-02-05011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218535-001CARBIDOPA, LEVODOPA AND ENTACAPONE12.5MG;200MG;50MGTABLET / ORALAB2026-02-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218535-002CARBIDOPA, LEVODOPA AND ENTACAPONE18.75MG;200MG;75MGTABLET / ORALAB2026-02-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218535-003CARBIDOPA, LEVODOPA AND ENTACAPONE25MG;200MG;100MGTABLET / ORALAB2026-02-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218535-004CARBIDOPA, LEVODOPA AND ENTACAPONE31.25MG;200MG;125MGTABLET / ORALAB2026-02-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218535-005CARBIDOPA, LEVODOPA AND ENTACAPONE37.5MG;200MG;150MGTABLET / ORALAB2026-02-05a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218535-006CARBIDOPA, LEVODOPA AND ENTACAPONE50MG;200MG;200MGTABLET / ORALAB2026-02-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A218535-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218535-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218535-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218535-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218535-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A218535-006AB1011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218535-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218535-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218535-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218535-004AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218535-005AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218535-006AB1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
carbidopa, levodopa and entacaponeCARBIDOPA, LEVODOPA AND ENTACAPONEAlembic Pharmaceuticals Inc.9d4e886e-edec-471d-b619-bf4828a6b7ce2026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218535
application number: ANDA218535
carbidopa, levodopa and entacaponeCARBIDOPA, LEVODOPA AND ENTACAPONEAlembic Pharmaceuticals Limited9ff83838-b7d0-4eec-98f2-fcc85789a1892026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 218535
application number: ANDA218535