Application 206032
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| 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 |
Orange Book products#
| 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#
| Application-product | TE code |
|---|---|
| A206032-001 | AB |
| A206032-002 | AB |
| A206032-003 | AB |
| A206032-004 | AB |
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 | 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 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | 2016-09-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206032-001 | MEMANTINE HYDROCHLORIDE | 7MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206032-002 | MEMANTINE HYDROCHLORIDE | 14MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206032-003 | MEMANTINE HYDROCHLORIDE | 21MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A206032-004 | MEMANTINE HYDROCHLORIDE | 28MG | CAPSULE, EXTENDED RELEASE / ORAL | 2016-09-28 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A206032-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206032-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206032-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A206032-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A206032-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A206032-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A206032-004 | AB | 1 | 6a471c1ec25d… |
| 2019-12-13 00:20 UTC | 2019-12 | A206032-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206032-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206032-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A206032-004 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206032-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206032-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206032-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A206032-004 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A206032-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206032-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206032-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A206032-004 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A206032-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206032-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206032-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A206032-004 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A206032-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206032-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206032-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A206032-004 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A206032-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A206032-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A206032-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A206032-004 | AB | 1 | 3f01610625f2… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Memantine Hydrochloride | MEMANTINE | Rising Pharma Holdings, Inc. | a282fbed-8304-458e-a0e9-5eaccc95339b | 2025-04-30 | Warnings, Adverse reactions | 206032 ANDA206032 |
NDC Listings For This Application#
| 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 |
|---|---|---|
| 45446 | ORIG | 2016-10-03 |