Home Applications 206310 Application 206310
Type ANDA
Sponsor MACLEODS PHARMS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 7MG No No 002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 14MG No No 003 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 21MG No No 004 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE;ORAL 28MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206310-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 A206310-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 A206310-003 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 A206310-004 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 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 2026-08-18 06:07:40 2026-07 A206310-001 MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206310-002 MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206310-003 MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A206310-004 MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206310-001 MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206310-002 MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206310-003 MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A206310-004 MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206310-001 MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206310-002 MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206310-003 MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206310-004 MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206310-001 MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206310-002 MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206310-003 MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206310-004 MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2025-08-28 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.
Documents# Document, Submission type, Date table Document Submission type Date 83266 ORIG 2025-09-03