Home Applications 206032 Application 206032
Type ANDA
Sponsor MYLAN 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 1 .
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 A206032-001 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE / ORAL AB 2016-09-28 A206032-002 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2016-09-28 A206032-003 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2016-09-28 A206032-004 MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2016-09-28
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 2026-08-01 22:54:32 2026-06 A206032-001 MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE / ORAL AB 2016-09-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A206032-002 MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE / ORAL AB 2016-09-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A206032-003 MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE / ORAL AB 2016-09-28 a50c72e98297…2026-08-01 22:54:32 2026-06 A206032-004 MEMANTINE HYDROCHLORIDE 28MG CAPSULE, EXTENDED RELEASE / ORAL AB 2016-09-28 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 9 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0378-5435 Memantine Hydrochloride memantine Mylan Pharmaceuticals Inc. ANDA Current 0378-5435 Memantine Hydrochloride memantine Mylan Pharmaceuticals Inc. ANDA Current 0378-5436 Memantine Hydrochloride memantine Mylan Pharmaceuticals Inc. ANDA Current 0378-5436 Memantine Hydrochloride memantine Mylan Pharmaceuticals Inc. ANDA Current 0378-5437 Memantine Hydrochloride memantine Mylan Pharmaceuticals Inc. ANDA Current 0378-5437 Memantine Hydrochloride memantine Mylan Pharmaceuticals Inc. ANDA Current 0378-5438 Memantine Hydrochloride memantine Mylan Pharmaceuticals Inc. ANDA Current 0378-5438 Memantine Hydrochloride memantine Mylan Pharmaceuticals Inc. ANDA Current 0378-5438 Memantine Hydrochloride memantine Mylan Pharmaceuticals Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 45446 ORIG 2016-10-03