Home Applications 214495 Application 214495
Type ANDA
Sponsor MACLEODS PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA TABLET;ORAL 12.5MG;200MG;50MG No No 002 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA TABLET;ORAL 18.75MG;200MG;75MG No No 003 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA TABLET;ORAL 25MG;200MG;100MG No No 004 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA TABLET;ORAL 31.25MG;200MG;125MG No No 005 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA TABLET;ORAL 37.5MG;200MG;150MG No No 006 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA TABLET;ORAL 50MG;200MG;200MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214495-001 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 12.5MG;200MG;50MG TABLET / ORAL AB 2025-04-15 A214495-002 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 18.75MG;200MG;75MG TABLET / ORAL AB 2025-04-15 A214495-003 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 25MG;200MG;100MG TABLET / ORAL AB 2025-04-15 A214495-004 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 31.25MG;200MG;125MG TABLET / ORAL AB 2025-04-15 A214495-005 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 37.5MG;200MG;150MG TABLET / ORAL AB 2025-04-15 A214495-006 CARBIDOPA, LEVODOPA AND ENTACAPONE CARBIDOPA; ENTACAPONE; LEVODOPA 50MG;200MG;200MG TABLET / ORAL AB 2025-04-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 6 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A214495-001 CARBIDOPA, LEVODOPA AND ENTACAPONE 12.5MG;200MG;50MG TABLET / ORAL AB 2025-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214495-002 CARBIDOPA, LEVODOPA AND ENTACAPONE 18.75MG;200MG;75MG TABLET / ORAL AB 2025-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214495-003 CARBIDOPA, LEVODOPA AND ENTACAPONE 25MG;200MG;100MG TABLET / ORAL AB 2025-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214495-004 CARBIDOPA, LEVODOPA AND ENTACAPONE 31.25MG;200MG;125MG TABLET / ORAL AB 2025-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214495-005 CARBIDOPA, LEVODOPA AND ENTACAPONE 37.5MG;200MG;150MG TABLET / ORAL AB 2025-04-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214495-006 CARBIDOPA, LEVODOPA AND ENTACAPONE 50MG;200MG;200MG TABLET / ORAL AB 2025-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214495-001 CARBIDOPA, LEVODOPA AND ENTACAPONE 12.5MG;200MG;50MG TABLET / ORAL AB 2025-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214495-002 CARBIDOPA, LEVODOPA AND ENTACAPONE 18.75MG;200MG;75MG TABLET / ORAL AB 2025-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214495-003 CARBIDOPA, LEVODOPA AND ENTACAPONE 25MG;200MG;100MG TABLET / ORAL AB 2025-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214495-004 CARBIDOPA, LEVODOPA AND ENTACAPONE 31.25MG;200MG;125MG TABLET / ORAL AB 2025-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214495-005 CARBIDOPA, LEVODOPA AND ENTACAPONE 37.5MG;200MG;150MG TABLET / ORAL AB 2025-04-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214495-006 CARBIDOPA, LEVODOPA AND ENTACAPONE 50MG;200MG;200MG TABLET / ORAL AB 2025-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214495-001 CARBIDOPA, LEVODOPA AND ENTACAPONE 12.5MG;200MG;50MG TABLET / ORAL AB 2025-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214495-002 CARBIDOPA, LEVODOPA AND ENTACAPONE 18.75MG;200MG;75MG TABLET / ORAL AB 2025-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214495-003 CARBIDOPA, LEVODOPA AND ENTACAPONE 25MG;200MG;100MG TABLET / ORAL AB 2025-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214495-004 CARBIDOPA, LEVODOPA AND ENTACAPONE 31.25MG;200MG;125MG TABLET / ORAL AB 2025-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214495-005 CARBIDOPA, LEVODOPA AND ENTACAPONE 37.5MG;200MG;150MG TABLET / ORAL AB 2025-04-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214495-006 CARBIDOPA, LEVODOPA AND ENTACAPONE 50MG;200MG;200MG TABLET / ORAL AB 2025-04-15 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214495-001 CARBIDOPA, LEVODOPA AND ENTACAPONE 12.5MG;200MG;50MG TABLET / ORAL AB 2025-04-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214495-002 CARBIDOPA, LEVODOPA AND ENTACAPONE 18.75MG;200MG;75MG TABLET / ORAL AB 2025-04-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214495-003 CARBIDOPA, LEVODOPA AND ENTACAPONE 25MG;200MG;100MG TABLET / ORAL AB 2025-04-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214495-004 CARBIDOPA, LEVODOPA AND ENTACAPONE 31.25MG;200MG;125MG TABLET / ORAL AB 2025-04-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214495-005 CARBIDOPA, LEVODOPA AND ENTACAPONE 37.5MG;200MG;150MG TABLET / ORAL AB 2025-04-15 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214495-006 CARBIDOPA, LEVODOPA AND ENTACAPONE 50MG;200MG;200MG TABLET / ORAL AB 2025-04-15 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.